<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/NCT04507503</url>
  </required_header>
  <id_info>
    <org_study_id>TAS-120-401</org_study_id>
    <nct_id>NCT04507503</nct_id>
  </id_info>
  <brief_title>Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements</brief_title>
  <official_title>An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taiho Oncology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taiho Oncology, Inc.</source>
  <brief_summary>
    <textblock>
      The objective of the study is to provide access to TAS-120 to patients With Advanced&#xD;
      Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label study to provide expanded access to TAS-120 prior to its commercial&#xD;
      availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene&#xD;
      Rearrangements who have failed standard therapy or who are unable to tolerate standard&#xD;
      therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Advanced Cholangiocarcinoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAS-120</intervention_name>
    <description>Futibatinib 20mg QD orally on a 28 days cycle</description>
    <other_name>Futibatinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provide written informed consent.&#xD;
&#xD;
          2. &gt;18 years of age.&#xD;
&#xD;
          3. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable&#xD;
             CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified&#xD;
             (CLIA-certified) laboratory.&#xD;
&#xD;
          4. Patient has failed standard therapy or standard therapy is not tolerated.&#xD;
&#xD;
          5. Has measurable or non-measurable lesion(s).&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.&#xD;
&#xD;
          7. Adequate organ function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus&#xD;
             homeostasis.&#xD;
&#xD;
          2. History and/or current evidence of clinically significant ectopic&#xD;
             mineralization/calcification.&#xD;
&#xD;
          3. History and/or current evidence of clinically significant retinal disorder confirmed&#xD;
             by retinal examination.&#xD;
&#xD;
          4. A serious illness or medical condition(s)&#xD;
&#xD;
          5. Pregnant or breast-feeding female&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Banner MD Anderson</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco (UCSF)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Division of Hematology-Oncology</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Center of Florida</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advent Health Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</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>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Cancer care</name>
      <address>
        <city>Grafton</city>
        <state>Wisconsin</state>
        <zip>53024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib</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>Futibatinib</mesh_term>
  </intervention_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/NCT04507503
org study id: TAS-120-401
nct id: NCT04507503
lead sponsor: 
The objective of the study is to provide access to TAS-120 to patients With Advanced
      Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.
This is an open-label study to provide expanded access to TAS-120 prior to its commercial
      availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene
      Rearrangements who have failed standard therapy or who are unable to tolerate standard
      therapy.
expanded access type treatment: Yes
intervention type: Drug
intervention name: TAS-120
description: Futibatinib 20mg QD orally on a 28 days cycle
other name: Futibatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
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country: United States
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Futibatinib