<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/NCT03029481</url>
  </required_header>
  <id_info>
    <org_study_id>17-000019</org_study_id>
    <secondary_id>JCCCID738</secondary_id>
    <nct_id>NCT03029481</nct_id>
  </id_info>
  <brief_title>Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma</brief_title>
  <official_title>Single Patient Expanded Access to Ganitumab for Metastatic Ewing Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NantCell, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</source>
  <brief_summary>
    <textblock>
      Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with&#xD;
      relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy&#xD;
      options. A large body of preclinical data supports a role for IGF-1R inhibition in the&#xD;
      treatment of Ewing sarcoma.&#xD;
&#xD;
      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-&#xD;
      agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human&#xD;
      monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded&#xD;
      access IND to provide our patient the opportunity to benefit from this treatment after having&#xD;
      developed progressive disease after multiple lines of prior therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with&#xD;
      relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy&#xD;
      options. A large body of preclinical data supports a role for IGF-1R inhibition in the&#xD;
      treatment of Ewing sarcoma.&#xD;
&#xD;
      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-&#xD;
      agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human&#xD;
      monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded&#xD;
      access IND to provide our patient the opportunity to benefit from this treatment after having&#xD;
      developed progressive disease after multiple lines of prior therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>Ewing Sarcoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ganitumab</intervention_name>
    <description>The patient will receive ganitumab, 18 mg/kg/dose intravenously every 2 weeks until clinical progression or decision to move to an alternate therapy.</description>
    <other_name>AMG 479</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosis: Confirmed translocation-positive Ewing sarcoma&#xD;
&#xD;
        Organ Function Requirements:&#xD;
&#xD;
        Serum creatinine &lt; 1.4 Adequate liver function&#xD;
&#xD;
          -  Total bilitubin &lt;1.5x upper limit of normal for age&#xD;
&#xD;
          -  SGPT (ALT) &lt; 5x upper limit of normal for age Adequate cardiac function &gt; 50% by&#xD;
             echocardiogram Bone Marrow&#xD;
&#xD;
          -  Absolute neutrophil count &gt; 750&#xD;
&#xD;
          -  Platelet count &gt; 75&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients of childbearing potential are not eligible unless a negative pregnancy&#xD;
             test result has been obtained. Lactating females are not eligible unless they have&#xD;
             agreed not to breastfeed their infants for the duration of protocol therapy. Sexually&#xD;
             active patients of reproductive potential are not eligible unless they have agreed to&#xD;
             use an effective contraceptive method for the duration of protocol therapy.&#xD;
&#xD;
          -  Patients with known pre-existing diabetes mellitus will be excluded from study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>48 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
  </eligibility>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 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>Sarcoma</mesh_term>
    <mesh_term>Sarcoma, Ewing</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/NCT03029481
org study id: 17-000019
secondary id: JCCCID738
nct id: NCT03029481
lead sponsor: 
collaborator: 
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with
      relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy
      options. A large body of preclinical data supports a role for IGF-1R inhibition in the
      treatment of Ewing sarcoma.

      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-
      agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human
      monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded
      access IND to provide our patient the opportunity to benefit from this treatment after having
      developed progressive disease after multiple lines of prior therapy.
Despite improvements in outcomes for patients with localized Ewing sarcoma, patients with
      relapsed metastatic Ewing sarcoma continue to have poor outcomes with current chemotherapy
      options. A large body of preclinical data supports a role for IGF-1R inhibition in the
      treatment of Ewing sarcoma.

      More recently, clinical trials of IGF-1R monoclonal antibodies have demonstrated single-
      agent activity in patients with relapsed Ewing sarcoma. Ganitumab (AMG 479) is a fully human
      monoclonal antibody directed against IGF-1R. We are proposing this single-agent expanded
      access IND to provide our patient the opportunity to benefit from this treatment after having
      developed progressive disease after multiple lines of prior therapy.
expanded access type individual: Yes
expanded access type treatment: Yes
intervention type: Drug
intervention name: Ganitumab
description: The patient will receive ganitumab, 18 mg/kg/dose intravenously every 2 weeks until clinical progression or decision to move to an alternate therapy.
other name: AMG 479
criteria: 
gender: All
minimum age: 48 Years
maximum age: 50 Years
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Sarcoma, Ewing