<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03790111</url>
  </required_header>
  <id_info>
    <org_study_id>LX1606.1-207-BTC</org_study_id>
    <secondary_id>LX1606.207</secondary_id>
    <secondary_id>LX1606.207</secondary_id>
    <nct_id>NCT03790111</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer</brief_title>
  <acronym>TELE-ABC</acronym>
  <official_title>A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TerSera Therapeutics LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TerSera Therapeutics LLC</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and&#xD;
      efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus&#xD;
      gemcitabine [gem])&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and&#xD;
      efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with&#xD;
      unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or&#xD;
      extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy&#xD;
      in the locally advanced or metastatic setting, and for which treatment with 1L therapy&#xD;
      (defined as a combination of cis plus gem) is planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis&#xD;
  </why_stopped>
  <start_date type="Actual">March 13, 2019</start_date>
  <completion_date type="Actual">January 13, 2022</completion_date>
  <primary_completion_date type="Actual">January 13, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment</measure>
    <time_frame>Month 6</time_frame>
    <description>Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions&quot;, or similar definition as accurate and appropriate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Project Overall Survival Rate at Month 6</measure>
    <time_frame>6 Months</time_frame>
    <description>Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months</time_frame>
    <description>Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Project Overall Survival Rate at Month 12</measure>
    <time_frame>12 Months</time_frame>
    <description>Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Progression Free Survival</measure>
    <time_frame>Month 12</time_frame>
    <description>Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR), Central Radiologist's Assessment</measure>
    <time_frame>Month 6</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR), Central Radiologist's Assessment</measure>
    <time_frame>Month 12</time_frame>
    <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR), Central Radiologist's Assessment</measure>
    <time_frame>End of Study up to 24 months</time_frame>
    <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment</measure>
    <time_frame>Month 6</time_frame>
    <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.&#xD;
(CR) + partial response (PR) at Months 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment</measure>
    <time_frame>Month 12</time_frame>
    <description>Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall (Objective) Response Rate, Central Radiologist's Assessment</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of Duration of Progression Free Survival, Local Radiologist's Assessment</measure>
    <time_frame>up to 7 months</time_frame>
    <description>Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival, Local Radiologist's Assessment</measure>
    <time_frame>Month 12</time_frame>
    <description>Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival, Local Radiologist's Assessment</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall (Objective) Response Rate, Local Read</measure>
    <time_frame>6 Months</time_frame>
    <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall (Objective) Response Rate, Local Reader's Assessment</measure>
    <time_frame>12 Months</time_frame>
    <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall (Objective) Response Rate (ORR), Local Reader's Assessment</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR), Local Reviewer</measure>
    <time_frame>Month 12 as defined by 1 year</time_frame>
    <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR), Local Reviewer</measure>
    <time_frame>Month 6</time_frame>
    <description>Disease control rate (DCR), Local Reviewer, 6 Months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate End of Study, Local Reviewer</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</measure>
    <time_frame>Month 6</time_frame>
    <description>Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</measure>
    <time_frame>Month 12</time_frame>
    <description>Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)</measure>
    <time_frame>Month 6</time_frame>
    <description>Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)</measure>
    <time_frame>Month 12</time_frame>
    <description>Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Change From Baseline</measure>
    <time_frame>Month 6</time_frame>
    <description>Mean change in weight at Month 6 from baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Change From Baseline</measure>
    <time_frame>Month 12</time_frame>
    <description>Mean change in weight at Month 12 from baseline measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Change From Baseline</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Mean change in weight from baseline to End of Study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Albumin</measure>
    <time_frame>Month 6</time_frame>
    <description>Mean change from Baseline to Month 6 serum albumin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Albumin</measure>
    <time_frame>Month 12</time_frame>
    <description>Mean change from Baseline to Month 12 serum albumin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Albumin</measure>
    <time_frame>End of Study as defined up to 24 months</time_frame>
    <description>Mean change from Baseline to End of Study serum albumin levels</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Biliary Tract Cancer (BTC)</condition>
  <arm_group>
    <arm_group_label>Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>telotristat ethyl</intervention_name>
    <description>XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study</description>
    <arm_group_label>Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg</arm_group_label>
    <other_name>telotristat ethyl + (cisplatin [cis] plus gemcitabine [gem])</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adults, ≥18 years of age. Patients of childbearing potential must agree&#xD;
             to use an adequate method of contraception during the study and for 30 days after the&#xD;
             last dose of XERMELO&#xD;
&#xD;
          -  Histopathologically or cytologically-confirmed, unresectable, locally advanced,&#xD;
             recurrent, or metastatic biliary tract cancer (BTC)&#xD;
&#xD;
          -  Naïve to tumor-directed therapy in locally advanced, unresectable, or metastatic&#xD;
             setting&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          -  Plans to initiate treatment with 1L therapy (cisplatin plus gemcitabine)&#xD;
&#xD;
          -  Ability to provide written informed consent prior to participation in any&#xD;
             study-related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to XERMELO, telotristat ethyl, telotristat etiprate, LX1032, or LX1606&#xD;
&#xD;
          -  Primary tumor site in the ampulla of Vater&#xD;
&#xD;
          -  Treatment with photodynamic therapy for localized disease or to relieve biliary&#xD;
             obstruction in the presence of metastatic disease within the past 30 days&#xD;
&#xD;
          -  Hematology laboratory values of: a. Absolute neutrophil count (ANC) ≤1,500 cells/mm^3;&#xD;
             or b. Platelets ≤100,000 cells/mm^3; or c. Hemoglobin (Hgb) ≤9 g/dL; or d. White blood&#xD;
             count (WBC) ≤3,000 cells/mm^3&#xD;
&#xD;
          -  Hepatic laboratory values of aspartate aminotransferase (AST) or alanine&#xD;
             aminotransferase (ALT): a. &gt;5 x upper limit of normal (ULN) if patient has documented&#xD;
             history of hepatic metastases; or b. &gt;2.5 x ULN if no liver metastases are present&#xD;
&#xD;
          -  Serum albumin &lt;2.8 g/dL&#xD;
&#xD;
          -  Total bilirubin &gt;1.5 x ULN or &gt;1.5 mg/dL&#xD;
&#xD;
          -  Prothrombin time (PT) or international normalized ratio (INR) &gt;1.5 x ULN&#xD;
&#xD;
          -  Serum creatinine or serum urea &gt;1.5 x ULN&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt;50 mL/min&#xD;
&#xD;
          -  Positive pregnancy test, pregnant, or breastfeeding&#xD;
&#xD;
          -  Any other clinically significant laboratory abnormality that would compromise patient&#xD;
             safety or the outcome of the study&#xD;
&#xD;
          -  Any clinically significant and/or uncontrolled cardiac-related abnormality that would&#xD;
             compromise patient safety or the outcome of the study&#xD;
&#xD;
          -  Myocardial infarction within the past 6 months&#xD;
&#xD;
          -  Active bleeding diathesis&#xD;
&#xD;
          -  Life expectancy ≤3 months&#xD;
&#xD;
          -  Current complaints of persistent constipation or history of chronic constipation,&#xD;
             bowel obstruction or fecaloma within the past 6 months&#xD;
&#xD;
          -  Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or&#xD;
             equivalent) or other immunosuppressive agent(s)&#xD;
&#xD;
          -  History and/or uncontrolled hepatitis B surface antigen (HBsAg), hepatitis C antibody&#xD;
             (HCV Ab), or human immunodeficiency virus (HIV)-1 or HIV-2&#xD;
&#xD;
          -  History of substance or alcohol abuse within the past 2 years&#xD;
&#xD;
          -  History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose&#xD;
             malabsorption&#xD;
&#xD;
          -  History of malignancy or active treatment for malignancy within 5 years&#xD;
&#xD;
          -  Receipt of live, attenuated vaccine or close contact with someone who has received a&#xD;
             live, attenuated vaccine within the past 1 month&#xD;
&#xD;
          -  Receipt of any investigational agent or study treatment (ie, any treatment or therapy&#xD;
             not approved by the FDA for the treatment of BTC) within the past 30 days&#xD;
&#xD;
          -  Receipt of any protein or antibody-based therapeutic agents within the past 3 months&#xD;
&#xD;
          -  Treatment with any tumor-directed therapy within the past 6 months with curative&#xD;
             intent&#xD;
&#xD;
          -  Existence of any surgical or medical condition that, in the judgment of the&#xD;
             Investigator, might compromise patient safety or the outcome of the study&#xD;
&#xD;
          -  Presence of any clinically significant findings (relative to the patient population)&#xD;
             during review of medical history or upon physical exam that, in the Investigator's or&#xD;
             Medical Monitor's opinion, would compromise patient safety or the outcome of the study&#xD;
&#xD;
          -  Evidence of brain metastases&#xD;
&#xD;
          -  Unable or unwilling to communicate or cooperate with the Investigator for any reason&#xD;
&#xD;
          -  Employee of Sponsor or clinical site, or relative of any member of a clinical site's&#xD;
             staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renuka Iyer, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Kim, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TerSera Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <results_first_submitted>December 16, 2022</results_first_submitted>
  <results_first_submitted_qc>April 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2023</results_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03790111/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03790111/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
          <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Primary endpoint was not met. Study was early terminated.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study did not meet its primary endpoint.</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
          <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.4" spread="10.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.4" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.9" spread="17.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.85" spread="6.343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Plasma 5-Hydroxyindoleacetic Acid (5-HIAA) Levels &lt;/= to ULN</title>
          <description>5-HIAA: Normal (&lt;/=) was considered &lt;/= 10.8 micrograms/Liter High (&gt;ULN) was considered &gt;10.8 micrograms/Liter</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;/= ULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;ULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum CA19-9</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Available</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum CEA</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Available</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Albumin</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Normal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Available</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment</title>
        <description>Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions&quot;, or similar definition as accurate and appropriate.</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment</title>
          <description>Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions&quot;, or similar definition as accurate and appropriate.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Safety Population</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responders, Central Reviewer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Responders, Central Reviewer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Per Protocol Population</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responders, Central Reviewer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Responders, Central Reviewer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>By Treatment Cycle Population</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Responders, Central Reviewer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Responders, Central Reviewer</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Project Overall Survival Rate at Month 6</title>
        <description>Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.</description>
        <time_frame>6 Months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Project Overall Survival Rate at Month 6</title>
          <description>Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.</description>
          <population>Safety Population</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" lower_limit="0.74" upper_limit="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.</description>
        <time_frame>First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.</description>
          <population>Safety Population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.667" lower_limit="11.567" upper_limit="NA">Due to insufficient number of participants with events, the upper margin cannot be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Project Overall Survival Rate at Month 12</title>
        <description>Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.</description>
        <time_frame>12 Months</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Project Overall Survival Rate at Month 12</title>
          <description>Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.</description>
          <population>Safety population</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" lower_limit="0.45" upper_limit="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Progression Free Survival</title>
        <description>Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Median Progression Free Survival</title>
          <description>Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.</description>
          <population>Safety Population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.233" lower_limit="4.067" upper_limit="7.467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR), Central Radiologist's Assessment</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;.</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR), Central Radiologist's Assessment</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR), Central Radiologist's Assessment</title>
        <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR), Central Radiologist's Assessment</title>
          <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR), Central Radiologist's Assessment</title>
        <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
        <time_frame>End of Study up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR), Central Radiologist's Assessment</title>
          <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment</title>
        <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.&#xD;
(CR) + partial response (PR) at Months 6</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment</title>
          <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.&#xD;
(CR) + partial response (PR) at Months 6</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment</title>
        <description>Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment</title>
          <description>Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall (Objective) Response Rate, Central Radiologist's Assessment</title>
        <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall (Objective) Response Rate, Central Radiologist's Assessment</title>
          <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of Duration of Progression Free Survival, Local Radiologist's Assessment</title>
        <description>Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.</description>
        <time_frame>up to 7 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Duration of Progression Free Survival, Local Radiologist's Assessment</title>
          <description>Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.</description>
          <population>Safety Population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.000" lower_limit="5.567" upper_limit="NA">Due to insufficient number of participants with events, the upper margin cannot be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival, Local Radiologist's Assessment</title>
        <description>Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival, Local Radiologist's Assessment</title>
          <description>Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.</description>
          <population>Safety Population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.467" lower_limit="5.567" upper_limit="10.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival, Local Radiologist's Assessment</title>
        <description>Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival, Local Radiologist's Assessment</title>
          <description>Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study</description>
          <population>Safety Population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.467" lower_limit="5.567" upper_limit="10.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall (Objective) Response Rate, Local Read</title>
        <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.</description>
        <time_frame>6 Months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall (Objective) Response Rate, Local Read</title>
          <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall (Objective) Response Rate, Local Reader's Assessment</title>
        <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.</description>
        <time_frame>12 Months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall (Objective) Response Rate, Local Reader's Assessment</title>
          <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall (Objective) Response Rate (ORR), Local Reader's Assessment</title>
        <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Overall (Objective) Response Rate (ORR), Local Reader's Assessment</title>
          <description>Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR), Local Reviewer</title>
        <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
        <time_frame>Month 12 as defined by 1 year</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR), Local Reviewer</title>
          <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR), Local Reviewer</title>
        <description>Disease control rate (DCR), Local Reviewer, 6 Months</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR), Local Reviewer</title>
          <description>Disease control rate (DCR), Local Reviewer, 6 Months</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate End of Study, Local Reviewer</title>
        <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate End of Study, Local Reviewer</title>
          <description>Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</title>
        <description>Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</title>
          <description>Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)</description>
          <population>Safety Population</population>
          <units>micrograms/Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.735" spread="8.6933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</title>
        <description>Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</title>
          <description>Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)</description>
          <population>Safety Population</population>
          <units>micrograms/Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.608" spread="6.5192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</title>
        <description>Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)</title>
          <description>Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)</description>
          <population>Safety Population</population>
          <units>micrograms/Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.154" spread="5.7003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)</title>
        <description>Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)</title>
          <description>Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
          <population>Safety Population</population>
          <units>U/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-229.82" spread="2484.902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)</title>
        <description>Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)</title>
          <description>Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
          <population>Safety Population</population>
          <units>U/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.04" spread="38.665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)</title>
        <description>Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)</title>
          <description>Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)</description>
          <population>Safety Population</population>
          <units>Units per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-153.98" spread="456.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Change From Baseline</title>
        <description>Mean change in weight at Month 6 from baseline measurement</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change From Baseline</title>
          <description>Mean change in weight at Month 6 from baseline measurement</description>
          <population>Safety Population</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="9.759"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Change From Baseline</title>
        <description>Mean change in weight at Month 12 from baseline measurement</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change From Baseline</title>
          <description>Mean change in weight at Month 12 from baseline measurement</description>
          <population>Safety Population</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="7.473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight Change From Baseline</title>
        <description>Mean change in weight from baseline to End of Study</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change From Baseline</title>
          <description>Mean change in weight from baseline to End of Study</description>
          <population>Safety Population</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.28" spread="8.920"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Albumin</title>
        <description>Mean change from Baseline to Month 6 serum albumin levels</description>
        <time_frame>Month 6</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Albumin</title>
          <description>Mean change from Baseline to Month 6 serum albumin levels</description>
          <population>Safety Population</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Albumin</title>
        <description>Mean change from Baseline to Month 12 serum albumin levels</description>
        <time_frame>Month 12</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Albumin</title>
          <description>Mean change from Baseline to Month 12 serum albumin levels</description>
          <population>Safety Population</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="2.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Albumin</title>
        <description>Mean change from Baseline to End of Study serum albumin levels</description>
        <time_frame>End of Study as defined up to 24 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
            <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Albumin</title>
          <description>Mean change from Baseline to End of Study serum albumin levels</description>
          <population>Safety Population</population>
          <units>g/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="4.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg</title>
          <description>Xermelo 250mg plus 1L therapy for a week, then Xermelo 500mg plus 1L therapy for the duration of the study&#xD;
telotristat ethyl: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood and lymphatic system disorders</sub_title>
                <description>Anemia Leukocytosis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Disorders</sub_title>
                <description>Acute myocardial infarction Atrial fibrillation Cardiac arrest Myocardial infarction</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders</sub_title>
                <description>Cholangitis Hepatobiliary disease Hyperbilirubinemia</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <description>Bacteremia Klebsiella bacteremia Pneumonia Sepsis Septic shock Urinary tract infection</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning and procedural complications</sub_title>
                <description>Post procedural hematuria</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <description>Blood bilirubin increased</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <description>Decreased appetite</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <description>Cerebrovascular accident Embolic stroke</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <description>Mental status changes</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, Thoracic and mediastinal disorders</sub_title>
                <description>Pulmonary embolism Chronic obstructive pulmonary disease Pleural effusion</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <description>Stevens-Johnson syndrome</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <description>Vena cava thrombosis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (21.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="34" subjects_affected="34" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="33" subjects_affected="33" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="32" subjects_affected="32" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was halted prematurely as it did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis.&#xD;
Due to early discontinuation of the study with limited data, the study results (data) at Month 12 and End of Study may be unreliable and uninterpretable.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Janine North, Executive Director-Clinical Development</name_or_title>
      <organization>TerSera Therapeutics Inc.</organization>
      <phone>888 600 8116</phone>
      <email>jnorth@tersera.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03790111
org study id: LX1606.1-207-BTC
secondary id: LX1606.207
secondary id: LX1606.207
nct id: NCT03790111
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and
      efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus
      gemcitabine [gem])
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and
      efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with
      unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or
      extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy
      in the locally advanced or metastatic setting, and for which treatment with 1L therapy
      (defined as a combination of cis plus gem) is planned.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
time frame: Month 6
description: Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
measure: Project Overall Survival Rate at Month 6
time frame: 6 Months
description: Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.
measure: Overall Survival (OS)
time frame: First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months
description: Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.
measure: Project Overall Survival Rate at Month 12
time frame: 12 Months
description: Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.
measure: Median Progression Free Survival
time frame: Month 12
description: Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
measure: Disease Control Rate (DCR), Central Radiologist's Assessment
time frame: Month 6
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
measure: Disease Control Rate (DCR), Central Radiologist's Assessment
time frame: Month 12
description: Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
measure: Disease Control Rate (DCR), Central Radiologist's Assessment
time frame: End of Study up to 24 months
description: Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
measure: Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
time frame: Month 6
description: Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
(CR) + partial response (PR) at Months 6
measure: Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
time frame: Month 12
description: Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.
measure: Overall (Objective) Response Rate, Central Radiologist's Assessment
time frame: End of Study as defined up to 24 months
description: Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
measure: Summary of Duration of Progression Free Survival, Local Radiologist's Assessment
time frame: up to 7 months
description: Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.
measure: Progression Free Survival, Local Radiologist's Assessment
time frame: Month 12
description: Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
measure: Progression Free Survival, Local Radiologist's Assessment
time frame: End of Study as defined up to 24 months
description: Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study
measure: Overall (Objective) Response Rate, Local Read
time frame: 6 Months
description: Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.
measure: Overall (Objective) Response Rate, Local Reader's Assessment
time frame: 12 Months
description: Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.
measure: Overall (Objective) Response Rate (ORR), Local Reader's Assessment
time frame: End of Study as defined up to 24 months
description: Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
measure: Disease Control Rate (DCR), Local Reviewer
time frame: Month 12 as defined by 1 year
description: Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
measure: Disease Control Rate (DCR), Local Reviewer
time frame: Month 6
description: Disease control rate (DCR), Local Reviewer, 6 Months
measure: Disease Control Rate End of Study, Local Reviewer
time frame: End of Study as defined up to 24 months
description: Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
measure: Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
time frame: Month 6
description: Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)
measure: Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
time frame: Month 12
description: Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)
measure: Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
time frame: End of Study as defined up to 24 months
description: Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)
measure: Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
time frame: Month 6
description: Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)
measure: Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
time frame: Month 12
description: Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)
measure: Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)
time frame: End of Study as defined up to 24 months
description: Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)
measure: Weight Change From Baseline
time frame: Month 6
description: Mean change in weight at Month 6 from baseline measurement
measure: Weight Change From Baseline
time frame: Month 12
description: Mean change in weight at Month 12 from baseline measurement
measure: Weight Change From Baseline
time frame: End of Study as defined up to 24 months
description: Mean change in weight from baseline to End of Study
measure: Change From Baseline in Serum Albumin
time frame: Month 6
description: Mean change from Baseline to Month 6 serum albumin levels
measure: Change From Baseline in Serum Albumin
time frame: Month 12
description: Mean change from Baseline to Month 12 serum albumin levels
measure: Change From Baseline in Serum Albumin
time frame: End of Study as defined up to 24 months
description: Mean change from Baseline to End of Study serum albumin levels
arm group label: Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg
arm group type: Experimental
description: Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study
intervention type: Drug
intervention name: telotristat ethyl
description: XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study
arm group label: Xermelo 250mg plus first line therapy for a week, then Xermelo 500mg
other name: telotristat ethyl + (cisplatin [cis] plus gemcitabine [gem])
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renuka Iyer, M.D.
role: Study Chair
affiliation: Roswell Park Cancer Institute
last name: Richard Kim, M.D.
role: Study Chair
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms
mesh term: Cisplatin
mesh term: Gemcitabine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was halted prematurely as it did not meet pre-specified Progression-Free Survival at Month 6 for Stage 2 Analysis.
Due to early discontinuation of the study with limited data, the study results (data) at Month 12 and End of Study may be unreliable and uninterpretable.
point of contact: 