<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/NCT03825484</url>
  </required_header>
  <id_info>
    <org_study_id>CR108489</org_study_id>
    <secondary_id>42756493MAF4001</secondary_id>
    <nct_id>NCT03825484</nct_id>
  </id_info>
  <brief_title>Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options</brief_title>
  <official_title>Expanded Access Program (EAP) for Patients With Advanced Cancers and FGFR Genetic Alterations Who Have Exhausted All Treatment Options</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Scientific Affairs, LLC</source>
  <brief_summary>
    <textblock>
      The purpose of this program is to provide participants an early access to erdafitinib prior&#xD;
      to market authorization (that is, Food and Drug Administration [FDA] approval in the United&#xD;
      States). The program is limited to participants with advanced cancers and fibroblast growth&#xD;
      factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of&#xD;
      care therapy and who are not eligible for an erdafitinib clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
  </expanded_access_info>
  <condition>Advanced Cancers and FGFR Genetic Alterations</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erdafitinib</intervention_name>
    <description>Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.</description>
    <other_name>JNJ-42756493</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has a documented fibroblast growth factor receptor (FGFR) alteration&#xD;
&#xD;
          -  Participant does not have co-morbidities that would alter risk-benefit of providing&#xD;
             erdafitinib (determined by treating physician's assessment)&#xD;
&#xD;
          -  Life expectancy is greater than (&gt;) 3 months (determined by treating physician's&#xD;
             assessment)&#xD;
&#xD;
          -  Participant has exhausted treatment options for their disease (review of prior&#xD;
             treatments)&#xD;
&#xD;
          -  Participant is not eligible for other erdafitinib clinical trials including but not&#xD;
             limited to BLC3001/NCT03390504 and BLC2002/NCT03473743&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Janssen Scientific Affairs, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Scientific Affairs, LLC</affiliation>
  </overall_official>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</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>Neoplasms</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/NCT03825484
org study id: CR108489
secondary id: 42756493MAF4001
nct id: NCT03825484
lead sponsor: 
The purpose of this program is to provide participants an early access to erdafitinib prior
      to market authorization (that is, Food and Drug Administration [FDA] approval in the United
      States). The program is limited to participants with advanced cancers and fibroblast growth
      factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of
      care therapy and who are not eligible for an erdafitinib clinical trial.
expanded access type intermediate: Yes
intervention type: Drug
intervention name: Erdafitinib
description: Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.
other name: JNJ-42756493
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Janssen Scientific Affairs, LLC Clinical Trial
role: Study Director
affiliation: Janssen Scientific Affairs, LLC
responsible party type: Sponsor
mesh term: Neoplasms