<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/NCT03762161</url>
  </required_header>
  <id_info>
    <org_study_id>IIT-2018-TAS-102</org_study_id>
    <nct_id>NCT03762161</nct_id>
  </id_info>
  <brief_title>A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer</brief_title>
  <official_title>A Phase II Study of TAS-102 in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rahul Parikh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taiho Oncology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the clinical benefit of TAS-102 in participants with metastatic&#xD;
      urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint&#xD;
      inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice&#xD;
      per day on Days 1-5 and Days 8-12 of each 28 day cycle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>Clinical benefit rate (complete response+ partial response+ stable disease)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival rate (PFS) among participants</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) among participants</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival rate (OS) among participants</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Evaluated per Medical Record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall change in patient-reported quality of life outcomes</measure>
    <time_frame>Up to 26 months</time_frame>
    <description>Evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores&#xD;
FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL.&#xD;
FACT-Bl includes five sub-scales:&#xD;
Physical Well-being (PWB), score range of 0-28&#xD;
Social/Family Well-being (SWB), score range of 0-28&#xD;
Emotional Well-being (EWB), score range of 0-24&#xD;
Functional Well-being (FWB), score range of 0-28&#xD;
Bladder Cancer Subscale (BlCS), score range of 0-48&#xD;
Note: Negatively stated items are reversed by subtracting the response from &quot;4&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events</measure>
    <time_frame>Up to 26 months</time_frame>
    <description>Evaluated per Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention TAS-102</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAS 102</intervention_name>
    <description>Participant self-administered orally at 35 milligrams per meter squared (mg/m2) twice daily Days 1-5 and 8-12 of every 28 day cycle</description>
    <arm_group_label>Intervention TAS-102</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability of participant to understand this study, and participant willingness to sign a&#xD;
             written informed consent.&#xD;
&#xD;
          -  Participants must have histologically or cytologically confirmed locally advanced&#xD;
             unresectable or metastatic urinary bladder (urothelial) cancer. Participants with&#xD;
             mixed histologies are permitted as long as transitional cell carcinoma is present in&#xD;
             the pathological specimen.&#xD;
&#xD;
          -  Participants must have measurable disease, defined as at least one lesion that can be&#xD;
             accurately measured in at least one dimension&#xD;
&#xD;
          -  Documented progression on or within 12 months of treatment with one previous&#xD;
             platinum-containing regimen or ineligible to receive platinum-containing regimen.&#xD;
             Neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-line&#xD;
             when participants progressed within 12 months of the last dose&#xD;
&#xD;
          -  Documented progression on prior checkpoint inhibitor or ineligible to receive&#xD;
             check-point inhibitor&#xD;
&#xD;
          -  Adequate performance status, organ, and marrow function.&#xD;
&#xD;
          -  Women of child-bearing potential and men with partners of child-bearing potential must&#xD;
             agree to practice sexual abstinence, or to use two forms of adequate contraception.&#xD;
&#xD;
          -  Men of child-bearing potential must not father a child or donate sperm while on this&#xD;
             study and for 6 months after their last study treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 4 weeks of&#xD;
             enrollment/registration.&#xD;
&#xD;
          -  Current or anticipated use of other investigational agents while participating in this&#xD;
             study.&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  Pregnant or breast feeding (if applicable).&#xD;
&#xD;
          -  Patients with known brain metastases&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to TAS 102.&#xD;
&#xD;
          -  Patients with HIV on anti-retro-viral therapy with thymidine kinase substrates, for&#xD;
             example, stavudine, zidovudine, telbivudine.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac&#xD;
             arrhythmia. Undergoing active treatment for a co-existing malignancy with the&#xD;
             exception of adequately treated basal cell carcinoma, squamous cell skin cancer,&#xD;
             thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy&#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>Rahul Parikh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Kansas Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KUCC Navigation</last_name>
    <phone>913-588-3671</phone>
    <email>kucc_navigation@kumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Kansas Cancer Center - Clinical Research Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KUCC Navigation</last_name>
      <phone>913-588-3671</phone>
      <email>kucc_navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Rahul Parikh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center, Westwood Campus</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KUCC Navigation</last_name>
      <phone>913-588-3671</phone>
      <email>kucc_navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Rahul Parikh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Rahul Parikh</investigator_full_name>
    <investigator_title>Principal Investigor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03762161
org study id: IIT-2018-TAS-102
nct id: NCT03762161
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study evaluates the clinical benefit of TAS-102 in participants with metastatic
      urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint
      inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice
      per day on Days 1-5 and Days 8-12 of each 28 day cycle.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical benefit rate (complete response+ partial response+ stable disease)
time frame: Up to 6 months
description: Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
measure: Progression-free survival rate (PFS) among participants
time frame: Up to 6 months
description: Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
measure: Overall response rate (ORR) among participants
time frame: Up to 12 months
description: Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
measure: Overall survival rate (OS) among participants
time frame: Up to 12 months
description: Evaluated per Medical Record
measure: Overall change in patient-reported quality of life outcomes
time frame: Up to 26 months
description: Evaluated per Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) version 4 - quality of life (QOL) questionnaire scores
FACT-Bl total score range is 0-156, derived by the sum of the sub-scales. Higher scores indicate better QOL.
FACT-Bl includes five sub-scales:
Physical Well-being (PWB), score range of 0-28
Social/Family Well-being (SWB), score range of 0-28
Emotional Well-being (EWB), score range of 0-24
Functional Well-being (FWB), score range of 0-28
Bladder Cancer Subscale (BlCS), score range of 0-48
Note: Negatively stated items are reversed by subtracting the response from "4".
measure: Proportion of participants with Grade 3 or higher Adverse and Serious Adverse Events
time frame: Up to 26 months
description: Evaluated per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
arm group label: Intervention TAS-102
arm group type: Experimental
intervention type: Drug
intervention name: TAS 102
description: Participant self-administered orally at 35 milligrams per meter squared (mg/m2) twice daily Days 1-5 and 8-12 of every 28 day cycle
arm group label: Intervention TAS-102
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rahul Parikh, MD
role: Principal Investigator
affiliation: The University of Kansas Cancer Center
last name: KUCC Navigation
phone: 913-588-3671
email: kucc_navigation@kumc.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Rahul Parikh
investigator title: Principal Investigor
mesh term: Urinary Bladder Neoplasms
sharing ipd: Undecided