<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/NCT03773302</url>
  </required_header>
  <id_info>
    <org_study_id>QBGJ398-301</org_study_id>
    <secondary_id>2018-004004-19</secondary_id>
    <nct_id>NCT03773302</nct_id>
  </id_info>
  <brief_title>Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations</brief_title>
  <official_title>A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>QED Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helsinn Healthcare SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>QED Therapeutics, Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor&#xD;
      (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.&#xD;
      The purpose of the study is to evaluate the efficacy and safety of the investigational agent&#xD;
      oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line&#xD;
      treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma&#xD;
      with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or&#xD;
      gemcitabine plus cisplatin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The sponsor has decided to close the study due to the discontinuation of infigratinib&#xD;
    development in oncology within the sponsor's territory. The discontinuation of the study was&#xD;
    not due to safety issues.&#xD;
  </why_stopped>
  <start_date type="Actual">December 27, 2019</start_date>
  <completion_date type="Actual">March 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multicenter, Open Label, 2:1 Randomized, Controlled Phase 3</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (central imaging assessment)</measure>
    <time_frame>Approximately 11 months on average</time_frame>
    <description>Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival in participants treated with infigratinib versus gemcitabine with cisplatin</measure>
    <time_frame>Approximately 15 months on average</time_frame>
    <description>Defined as time from date of randomization until death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin</measure>
    <time_frame>Approximately 10 months on average</time_frame>
    <description>Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by overall response rate (ORR) determined by blinded independent central assessment and the investigator.</measure>
    <time_frame>Approximately 10 months on average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by best overall response (BOR) determined by blinded independent central assessment and the investigator.</measure>
    <time_frame>Approximately 10 months on average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by duration of response (DOR) determined by blinded independent central assessment and the investigator.</measure>
    <time_frame>Approximately 10 months on average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by disease control rate (PR+CR+SD) determined by blinded independent central assessment and the investigator.</measure>
    <time_frame>Approximately 10 months on average</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability of infigratinib.</measure>
    <time_frame>Approximately from baseline to last dose date of study treatment + 30 days, approximately 12 months on average</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Advanced Cholangiocarcinoma</condition>
  <condition>FGFR2 Gene Mutation</condition>
  <arm_group>
    <arm_group_label>Infigratinib (BGJ398) 125 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gemcitabine + Cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BGJ398</intervention_name>
    <description>Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.</description>
    <arm_group_label>Infigratinib (BGJ398) 125 mg</arm_group_label>
    <other_name>Infigratinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.</description>
    <arm_group_label>Gemcitabine + Cisplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.</description>
    <arm_group_label>Gemcitabine + Cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed unresectable locally advanced or metastatic&#xD;
             cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma&#xD;
             are not eligible&#xD;
&#xD;
          -  Have written documentation of local laboratory or central laboratory determination of&#xD;
             a known or likely activating FGFR2 fusion/rearrangement from a sample collected before&#xD;
             randomization&#xD;
&#xD;
          -  Have an archival tumor tissue sample available with sufficient tumor content for FGFR2&#xD;
             fusion/rearrangement molecular testing by the central laboratory. However, if an&#xD;
             archival tumor tissue sample is not available, or does not meet requirements for&#xD;
             central testing a newly obtained (before randomization) tumor biopsy may be submitted&#xD;
             instead. If a prestudy written documentation of FGFR2 fusion/rearrangement in tumor&#xD;
             tissue is available from the central laboratory, an additional tumor sample does not&#xD;
             need to be submitted.&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1&#xD;
&#xD;
          -  Are able to swallow and retain oral medication&#xD;
&#xD;
          -  Are willingness to avoid pregnancy or father children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received treatment with any systemic anti-cancer therapy for unresectable locally&#xD;
             advanced or metastatic cholangiocarcinoma, with following exceptions&#xD;
&#xD;
               1. Prior neoadjuvant or adjuvant therapy is permitted if completed &gt; 6 months after&#xD;
                  the last dose of neoadjuvant or adjuvant therapy.&#xD;
&#xD;
               2. One cycle of gemcitabine-based chemotherapy for locally advanced or metastatic&#xD;
                  cholangiocarcinoma is permitted before randomization&#xD;
&#xD;
          -  History of a liver transplant&#xD;
&#xD;
          -  Received previously or currently is receiving treatment with a mitogen activated&#xD;
             protein kinase kinase (MEK) or selective FGFR inhibitor&#xD;
&#xD;
          -  Have impairment of gastrointestinal (GI) function or GI disease that may significantly&#xD;
             alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled&#xD;
             nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).&#xD;
&#xD;
          -  Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g.,&#xD;
             parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis&#xD;
             etc.&#xD;
&#xD;
          -  History and/or current evidence of extensive tissue calcification including, but not&#xD;
             limited to, the soft tissue, kidneys, intestine, myocardium, vascular system and lung&#xD;
             with the exception of calcified lymph nodes, minor pulmonary parenchymal&#xD;
             calcifications, and asymptomatic coronary calcification&#xD;
&#xD;
          -  Current evidence of corneal or retinal disorder/keratopathy&#xD;
&#xD;
          -  Receiving and continued treatment or are planning to receive agents or consuming foods&#xD;
             that are known moderate or strong inducers or inhibitors of CYP3A4 and medications&#xD;
             which increase serum phosphorus and/or calcium concentration&#xD;
&#xD;
          -  Clinically significant or uncontrolled cardiac disease&#xD;
&#xD;
          -  Recent (≤ 3 months prior to first dose of study drug) transient ischemic attack or&#xD;
             stroke&#xD;
&#xD;
          -  Severe hearing loss&#xD;
&#xD;
          -  Severe neuropathy&#xD;
&#xD;
          -  History of another primary malignancy within 3 years except adequately treated in-situ&#xD;
             carcinoma of the cervix or non-melanoma skin cancer or other curatively treated&#xD;
             malignancy that is not expected to require treatment&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Have known microsatellite instability-high (MSI-H) disease and the decision is made by&#xD;
             the treating investigator that an alternative, non-study therapy is warranted&#xD;
             according to standard of care.&#xD;
&#xD;
          -  Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents,&#xD;
             infigratinib, or their excipients&#xD;
&#xD;
          -  Have any contraindication to cisplatin or gemcitabine treatment according to local&#xD;
             labeling or standard institutional practice.&#xD;
&#xD;
          -  Have taken any Chinese herbal medicine or Chinese patent medicine treatments with&#xD;
             anticancer activity within 14 days of the first dose of study drug.&#xD;
&#xD;
          -  Have received a live vaccine within 30 days before the first dose of study drug or are&#xD;
             planning to receive a live vaccine during participation in this study&#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>Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>QED Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Norris Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Medical Group</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Cancer Center at Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center - New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Hematology Centers of Western Michigan</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute - Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Oncology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health and Hospital System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75343</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chris O'Brien Lifehouse Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blacktown Hospital</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Bentleigh East</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula &amp; South Eastern Haematology and Oncology Group</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St John of God Hospital Subiaco</name>
      <address>
        <city>Subiaco</city>
        <state>Western Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <state>Brussels</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hopital de Charleroi</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Josephs Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <zip>410006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou First People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Hubei</city>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Zhongshan</city>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <state>Val-de-Marne</state>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges-Francois Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupement Hospitalier Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Nord Franche-Comte</name>
      <address>
        <city>Montbéliard</city>
        <zip>25200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Archet I Et II</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L'Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Wurttemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Dortmund gGmbH</name>
      <address>
        <city>Dortmund</city>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale di Cremona (ASST)</name>
      <address>
        <city>Cremona</city>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto - I.R.C.C.S.</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Biomedico Di Roma</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMG - SNU Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Beatriz Angelo</name>
      <address>
        <city>Loures</city>
        <state>Lisboa</state>
        <zip>2674-514</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Garcia de Orta</name>
      <address>
        <city>Almada</city>
        <zip>2801-951</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar E Universitário de Coimbra EPE</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Descobertas</name>
      <address>
        <city>Lisboa</city>
        <zip>1998-018</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.</name>
      <address>
        <city>Lisbon</city>
        <zip>1099-023</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto - Hospital de Santo António</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de São João, E.P.E.</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Oncologico, Puerto Rico Medical Center</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragon</state>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial Universitario de Salamanca - Hospital Clinico</name>
      <address>
        <city>Salamanca</city>
        <state>Castilla Y Leon</state>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Cataluna</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Catalan de Oncologio ICO I'Hospitalet</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebrón - PPDS</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro - CIOCC</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan City</city>
        <state>Tainan</state>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital - YunLin Branch</name>
      <address>
        <city>Huwei</city>
        <zip>632</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital - Kaohsiung</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Hospital, Liouying</name>
      <address>
        <city>Tainan</city>
        <zip>73657</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Songklanagarind Hospital, Prince of Songkla University</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramathibodi Hospital Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maharaj Nakorn Chiang Mai Chiang Mai University</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Srinagarind Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naresuan University</name>
      <address>
        <city>Phitsanulok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Clatterbridge Cancer Centre NHS Foundation Trust</name>
      <address>
        <city>Bebington</city>
        <state>Wirral</state>
        <zip>CH63 4JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust - PPDS</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cholangiocarcinoma</keyword>
  <keyword>unresectable cholangiocarcinoma</keyword>
  <keyword>metastatic cholangiocarcinoma</keyword>
  <keyword>fibroblast growth factor receptor inhibitor</keyword>
  <keyword>FGFR2</keyword>
  <keyword>FGFR2 gene fusions/translocations</keyword>
  <keyword>BGJ398</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Infigratinib</mesh_term>
  </intervention_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/NCT03773302
org study id: QBGJ398-301
secondary id: 2018-004004-19
nct id: NCT03773302
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor
      (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.
      The purpose of the study is to evaluate the efficacy and safety of the investigational agent
      oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line
      treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma
      with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or
      gemcitabine plus cisplatin.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, Open Label, 2:1 Randomized, Controlled Phase 3
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (central imaging assessment)
time frame: Approximately 11 months on average
description: Defined as the time from randomization until date of disease progression by blinded independent central imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.
measure: Overall survival in participants treated with infigratinib versus gemcitabine with cisplatin
time frame: Approximately 15 months on average
description: Defined as time from date of randomization until death due to any cause
measure: Investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin
time frame: Approximately 10 months on average
description: Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.
measure: Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by overall response rate (ORR) determined by blinded independent central assessment and the investigator.
time frame: Approximately 10 months on average
measure: Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by best overall response (BOR) determined by blinded independent central assessment and the investigator.
time frame: Approximately 10 months on average
measure: Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by duration of response (DOR) determined by blinded independent central assessment and the investigator.
time frame: Approximately 10 months on average
measure: Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by disease control rate (PR+CR+SD) determined by blinded independent central assessment and the investigator.
time frame: Approximately 10 months on average
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability of infigratinib.
time frame: Approximately from baseline to last dose date of study treatment + 30 days, approximately 12 months on average
arm group label: Infigratinib (BGJ398) 125 mg
arm group type: Experimental
description: Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
arm group label: Gemcitabine + Cisplatin
arm group type: Active Comparator
description: Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib if certain criteria are met.
intervention type: Drug
intervention name: BGJ398
description: Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
arm group label: Infigratinib (BGJ398) 125 mg
other name: Infigratinib
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
arm group label: Gemcitabine + Cisplatin
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
arm group label: Gemcitabine + Cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Development
role: Study Director
affiliation: QED Therapeutics
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country: Australia
country: Belgium
country: Canada
country: China
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Portugal
country: Puerto Rico
country: Spain
country: Taiwan
country: Thailand
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Gemcitabine
mesh term: Infigratinib
sharing ipd: Undecided