<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/NCT04479904</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1020-II-204</org_study_id>
    <nct_id>NCT04479904</nct_id>
  </id_info>
  <brief_title>A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma</brief_title>
  <official_title>A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</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>
      This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe&#xD;
      and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic&#xD;
      Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    It is difficult to screening subject&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 10, 2020</start_date>
  <completion_date type="Anticipated">February 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Objective response rate per RECIST 1.1</measure>
    <time_frame>up to 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
    <description>Duration of Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
    <description>Disease Control Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
    <description>Progression-Free-Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AE) and serious adverse event (SAE)</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
    <description>Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of famitinib and its N-desethyl metabolite</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Intrahepatic Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>famitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famitinib</intervention_name>
    <description>po</description>
    <arm_group_label>famitinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary participation and written informed consent;&#xD;
&#xD;
          2. Aged 18-75 years (inclusive), males and females;&#xD;
&#xD;
          3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed&#xD;
             first-line systematic chemotherapy;&#xD;
&#xD;
          4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central&#xD;
             laboratory;&#xD;
&#xD;
          5. At least one measurable lesion that has not been treated locally;&#xD;
&#xD;
          6. ECOG score of 0-1;&#xD;
&#xD;
          7. Expected survival ≥ 12 weeks;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of multiple factors affecting oral medications;&#xD;
&#xD;
          2. Wounds unhealed over a long period of time, or fractures not completely healed;&#xD;
&#xD;
          3. Known or suspected allergy to investigational drug or any drug related to this trial.&#xD;
&#xD;
          4. Known cases of CNS(Central Nervous System) metastasis;&#xD;
&#xD;
          5. Uncontrolled cardiac diseases or symptoms;&#xD;
&#xD;
          6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a&#xD;
             history of organ transplants;&#xD;
&#xD;
          7. Patients previously treated with FGFR inhibitors (such as erdafitinib)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</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>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04479904
org study id: SHR-1020-II-204
nct id: NCT04479904
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe
      and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic
      Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate per RECIST 1.1
time frame: up to 24 months
measure: DOR
time frame: At pre-defined intervals from initial dose up to 24 months
description: Duration of Response
measure: DCR
time frame: At pre-defined intervals from initial dose up to 24 months
description: Disease Control Rate
measure: PFS
time frame: At pre-defined intervals from initial dose up to 24 months
description: Progression-Free-Survival
measure: OS
time frame: At pre-defined intervals from initial dose up to 24 months
description: Overall survival
measure: Adverse events (AE) and serious adverse event (SAE)
time frame: At pre-defined intervals from initial dose up to 24 months
description: Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug
measure: Plasma concentrations of famitinib and its N-desethyl metabolite
time frame: At pre-defined intervals from initial dose up to 24 months
arm group label: famitinib
arm group type: Experimental
intervention type: Drug
intervention name: Famitinib
description: po
arm group label: famitinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Cholangiocarcinoma