<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/NCT02966821</url>
  </required_header>
  <id_info>
    <org_study_id>2016-012-00CH1</org_study_id>
    <nct_id>NCT02966821</nct_id>
  </id_info>
  <brief_title>Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma</brief_title>
  <official_title>A Phase II, Single-arm, Open-label, Multicenter Study to Assess the Efficacy and Safety of Surufatinib as a Second-line Treatment in Patients With Surgically Unresectable or Metastatic Biliary Tract Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hutchison Medipharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hutchmed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of&#xD;
      Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic&#xD;
      biliary tract carcinoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week&#xD;
      PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer&#xD;
      patients without progression or death out of these 16 patients at week 16, the study will be&#xD;
      stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable&#xD;
      patients.&#xD;
&#xD;
      Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for&#xD;
      every 28-day treatment cycle until disease progression, death, intolerable toxicity or other&#xD;
      protocol specified end-of-treatment criteria is met (which comes first).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 17, 2018</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>Progression-free survival (PFS) rate at Week 16</measure>
    <time_frame>Progression-free survival (PFS) rate at Week 16</time_frame>
    <description>Proportion of patients without PD or death at Week 16</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03</measure>
    <time_frame>From first dose to within 30 days after the last dose</time_frame>
    <description>AE monitored from the first dose to within 30 days after the last dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes</measure>
    <time_frame>From first dose to within 30 days after the last dose</time_frame>
    <description>Safety parameters monitored from the first dose to within 30 days after the last dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>6 months after the last patient enrolled</time_frame>
    <description>Proportion of patients with a best overall CR and PR per RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>6 months after the last patient enrolled</time_frame>
    <description>Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR)</measure>
    <time_frame>6 months after the last patient enrolled</time_frame>
    <description>The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>6 months after the last patient enrolled</time_frame>
    <description>The time from the start date of study drug until the date of objective disease progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>6 months after the last patient enrolled</time_frame>
    <description>The time interval between the start date of study drug and the date of death (any cause)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Biliary Tract Cancer</condition>
  <arm_group>
    <arm_group_label>Surufatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surufatinib 300mg once-daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Surufatinib</intervention_name>
    <description>Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)</description>
    <arm_group_label>Surufatinib</arm_group_label>
    <other_name>HMPL-012 and Sulfatinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of written Informed Consent Form (ICF) prior to any study specific&#xD;
             procedures&#xD;
&#xD;
          2. Aged at least 18 years&#xD;
&#xD;
          3. Histologically or cytologically confirmed advanced BTC that was surgically&#xD;
             unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC),&#xD;
             intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC)&#xD;
&#xD;
          4. First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable&#xD;
             toxicities&#xD;
&#xD;
          5. ECOG 0-1&#xD;
&#xD;
          6. Patients must have measurable lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anti-tumor therapy received within 4 weeks prior to initiation of study treatment&#xD;
&#xD;
          2. Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase&#xD;
             inhibitors or monoclonal antibody&#xD;
&#xD;
          3. Liver metastases ≥50% of liver volume&#xD;
&#xD;
          4. Child-Pugh classification score of liver function&gt; 7&#xD;
&#xD;
          5. History or presence of a serious hemorrhage (&gt;30 ml within 3 months), hemoptysis (&gt;5&#xD;
             ml blood within 4 weeks) or a thromboembolic event (including transient ischemic&#xD;
             attack and/or stroke events) within 12 months&#xD;
&#xD;
          6. Active malignancy (except for definitively treated basal or squamous cell carcinoma of&#xD;
             the skin, or carcinoma in-situ of the cervix) within the past 5 years&#xD;
&#xD;
          7. Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks&#xD;
&#xD;
          8. Pregnancy ( positive pregnancy test before the first dose of study treatment) or&#xD;
             lactating women&#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>Jianming Xu, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The 307th Hospital of Military Chinese People's Liberation Army</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 307th Hospital of Military Chinese People's Liberation Army</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilongjiang Cancer Hospital</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <zip>150040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin medical university cancer institute&amp;hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surufatinib</keyword>
  <keyword>Biliary Tract Cancer</keyword>
  <keyword>Second-line</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02966821
org study id: 2016-012-00CH1
nct id: NCT02966821
lead sponsor: 
has dmc: No
A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of
      Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic
      biliary tract carcinoma
This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week
      PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer
      patients without progression or death out of these 16 patients at week 16, the study will be
      stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable
      patients.

      Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for
      every 28-day treatment cycle until disease progression, death, intolerable toxicity or other
      protocol specified end-of-treatment criteria is met (which comes first).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS) rate at Week 16
time frame: Progression-free survival (PFS) rate at Week 16
description: Proportion of patients without PD or death at Week 16
measure: Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
time frame: From first dose to within 30 days after the last dose
description: AE monitored from the first dose to within 30 days after the last dose
measure: Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes
time frame: From first dose to within 30 days after the last dose
description: Safety parameters monitored from the first dose to within 30 days after the last dose
measure: Objective response rate (ORR)
time frame: 6 months after the last patient enrolled
description: Proportion of patients with a best overall CR and PR per RECIST v1.1
measure: Disease control rate (DCR)
time frame: 6 months after the last patient enrolled
description: Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1
measure: Duration of response (DoR)
time frame: 6 months after the last patient enrolled
description: The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death
measure: Progression-free survival (PFS)
time frame: 6 months after the last patient enrolled
description: The time from the start date of study drug until the date of objective disease progression or death
measure: Overall survival (OS)
time frame: 6 months after the last patient enrolled
description: The time interval between the start date of study drug and the date of death (any cause)
arm group label: Surufatinib
arm group type: Experimental
description: Surufatinib 300mg once-daily
intervention type: Drug
intervention name: Surufatinib
description: Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
arm group label: Surufatinib
other name: HMPL-012 and Sulfatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jianming Xu, Prof.
role: Principal Investigator
affiliation: The 307th Hospital of Military Chinese People's Liberation Army
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms
sharing ipd: No