<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/NCT03801278</url>
  </required_header>
  <id_info>
    <org_study_id>FPA144-006</org_study_id>
    <nct_id>NCT03801278</nct_id>
  </id_info>
  <brief_title>An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer</brief_title>
  <acronym>FPA144</acronym>
  <official_title>An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Five Prime Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Five Prime Therapeutics, Inc.</source>
  <brief_summary>
    <textblock>
      This is an open-label, expanded access protocol to continue administration of bemarituzumab&#xD;
      (FPA144) in a single patient with recurrent bladder cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol is intended to provide access to bemarituzumab (FPA144 an investigational&#xD;
      agent) to a single patient with recurrent bladder cancer who had a response to study drug on&#xD;
      FPA144-001. That study is closing and this expanded access protocol allows this single&#xD;
      patient to continue receiving this agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Recurrent Bladder Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FPA144</intervention_name>
    <description>Bemarituzumab administration every two weeks</description>
    <other_name>Bemarituzumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Understand and sign an Institutional Review Board-approved informed consent form prior&#xD;
             to receiving bemarituzumab&#xD;
&#xD;
          2. Previously enrolled on the FPA144-001 study, received bemarituzumab and obtained&#xD;
             clinical benefit from the investigational product (IP) administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Pregnancy and lactation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>December 9, 2021</last_update_submitted>
  <last_update_submitted_qc>December 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Single patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bemarituzumab</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/NCT03801278
org study id: FPA144-006
nct id: NCT03801278
lead sponsor: 
This is an open-label, expanded access protocol to continue administration of bemarituzumab
      (FPA144) in a single patient with recurrent bladder cancer
This protocol is intended to provide access to bemarituzumab (FPA144 an investigational
      agent) to a single patient with recurrent bladder cancer who had a response to study drug on
      FPA144-001. That study is closing and this expanded access protocol allows this single
      patient to continue receiving this agent.
expanded access type individual: Yes
intervention type: Drug
intervention name: FPA144
description: Bemarituzumab administration every two weeks
other name: Bemarituzumab
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Recurrence
mesh term: Bemarituzumab