<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/NCT03025360</url>
  </required_header>
  <id_info>
    <org_study_id>20366</org_study_id>
    <nct_id>NCT03025360</nct_id>
  </id_info>
  <brief_title>Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion</brief_title>
  <official_title>Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <brief_summary>
    <textblock>
      Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene&#xD;
      fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other&#xD;
      considerations that prevent access to larotrectinib through an existing clinical trial. Gene&#xD;
      fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion&#xD;
      can lead to the development of solid tumors in a variety of tissue types. The study drug&#xD;
      larotrectinib blocks the action of the NTRK gene fusion.&#xD;
&#xD;
      Expanded access is intended to treat individual patients with different types of cancers with&#xD;
      a NTRK gene fusion who are unresponsive to current standard treatment for their condition and&#xD;
      also are unable to participate in ongoing clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Tumors Harboring NTRK Fusion</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Larotrectinib (Vitrakvi, BAY2757556)</intervention_name>
    <description>Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.</description>
    <other_name>LOXO-101</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion&#xD;
&#xD;
          -  Subjects are unable to participate in an ongoing larotrectinib clinical trial&#xD;
&#xD;
          -  Medically suitable for treatment with larotrectinib&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in an ongoing clinical study of larotrectinib or another TRK&#xD;
             inhibitor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>December 18, 2019</last_update_submitted>
  <last_update_submitted_qc>December 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neurotrophic tyrosine receptor kinase (NTRK)</keyword>
  <keyword>NTRK1</keyword>
  <keyword>NTRK2</keyword>
  <keyword>NTRK3</keyword>
  <keyword>Fusion Positive</keyword>
  <!-- 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/NCT03025360
org study id: 20366
nct id: NCT03025360
lead sponsor: 
Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene
      fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other
      considerations that prevent access to larotrectinib through an existing clinical trial. Gene
      fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion
      can lead to the development of solid tumors in a variety of tissue types. The study drug
      larotrectinib blocks the action of the NTRK gene fusion.

      Expanded access is intended to treat individual patients with different types of cancers with
      a NTRK gene fusion who are unresponsive to current standard treatment for their condition and
      also are unable to participate in ongoing clinical trials.
expanded access type individual: Yes
intervention type: Drug
intervention name: Larotrectinib (Vitrakvi, BAY2757556)
description: Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.
other name: LOXO-101
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor