xml: <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/NCT05999994</url>
    </required_header>
    <id_info>
      <org_study_id>17304</org_study_id>
      <secondary_id>J1S-MC-JAAA</secondary_id>
      <nct_id>NCT05999994</nct_id>
    </id_info>
    <brief_title>A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer</brief_title>
    <acronym>CAMPFIRE</acronym>
    <official_title>CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eli Lilly and Company</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of the master is to help the research sites and sponsor carry out several&#xD;
        clinical trials more efficiently by providing a common research protocol. Individual clinical&#xD;
        trials under this master protocol define drug/disease-specific research goals and activities&#xD;
        to test them. New studies will be added as new drugs emerge against different cancers.&#xD;
        Participation in the trial will depend on how long the benefit lasts.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 22, 2020</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>Yes</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants Allocated to Each ISA</measure>
      <time_frame>Baseline up to Week 4</time_frame>
      <description>Number of Participants Allocated to Each ISA</description>
    </primary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">105</enrollment>
    <condition>Neoplasms</condition>
    <condition>Child</condition>
    <condition>Adolescent</condition>
    <arm_group>
      <arm_group_label>Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ramucirumab + Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Abemaciclib + Irinotecan + Temozolomide (ES ISA)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Irinotecan + Temozolomide (ES ISA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ramucirumab</intervention_name>
      <description>Administered IV</description>
      <arm_group_label>Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
      <arm_group_label>Ramucirumab + Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
      <other_name>LY3009806</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cyclophosphamide</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
      <arm_group_label>Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vinorelbine</intervention_name>
      <description>Administered IV</description>
      <arm_group_label>Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
      <arm_group_label>Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>Administered IV</description>
      <arm_group_label>Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
      <arm_group_label>Ramucirumab + Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
      <other_name>LY188011</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Docetaxel</intervention_name>
      <description>Administered IV</description>
      <arm_group_label>Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
      <arm_group_label>Ramucirumab + Gemcitabine + Docetaxel (SS ISA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Abemaciclib</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>Abemaciclib + Irinotecan + Temozolomide (ES ISA)</arm_group_label>
      <other_name>LY2835219</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Irinotecan</intervention_name>
      <description>Administered IV</description>
      <arm_group_label>Abemaciclib + Irinotecan + Temozolomide (ES ISA)</arm_group_label>
      <arm_group_label>Irinotecan + Temozolomide (ES ISA)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Temozolomide</intervention_name>
      <description>Administered orally</description>
      <arm_group_label>Abemaciclib + Irinotecan + Temozolomide (ES ISA)</arm_group_label>
      <arm_group_label>Irinotecan + Temozolomide (ES ISA)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Participants must meet all of the inclusion criteria below. Additional criteria are&#xD;
          specified in the protocol amendment (individual addenda) to which the participant will&#xD;
          enroll.&#xD;
  &#xD;
            -  Have either measurable or evaluable disease using standard techniques by the Response&#xD;
               Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).&#xD;
  &#xD;
            -  The participant has a Lansky (&lt;16 years of age) or Karnofsky (≥16 years of age)&#xD;
               performance score of at least 50.&#xD;
  &#xD;
            -  Participants must have discontinued all previous treatments for cancer or&#xD;
               investigational agents greater than or equal to (≥)7 days after the last dose and must&#xD;
               have recovered from clinically significant side effects.&#xD;
  &#xD;
            -  The participant has adequate hematologic and organ function.&#xD;
  &#xD;
            -  Female participants of childbearing potential must have a negative urine or serum&#xD;
               pregnancy test within 7 days prior to first dose.&#xD;
  &#xD;
            -  Both female and male participants of childbearing potential must agree to use highly&#xD;
               effective contraceptive precautions during the trial and for at least 3 months&#xD;
               following the last dose of study drug.&#xD;
  &#xD;
          Participants will be ineligible if they meet any of the exclusion criteria below.&#xD;
          Additional criteria are specified in the protocol amendment to which the participant will&#xD;
          enroll.&#xD;
  &#xD;
            -  Participants with severe and/or uncontrolled concurrent medical disease or psychiatric&#xD;
               illness/social situation that, in the opinion of the investigator, could cause&#xD;
               unacceptable safety risks or compromise compliance with the protocol.&#xD;
  &#xD;
            -  Participants who have active infections requiring therapy.&#xD;
  &#xD;
            -  Participants who have had allogeneic bone marrow or solid organ transplant.&#xD;
  &#xD;
            -  Participants who have had, or are planning to have, certain invasive procedures.&#xD;
  &#xD;
            -  Female participants who are pregnant or breastfeeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 Eastern time (UTC/GMT - 5 hours, EST)</last_name>
      <role>Study Director</role>
      <affiliation>Eli Lilly and Company</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>Clinicaltrials.gov@lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Leids Universitair Medisch Centrum</name>
        <address>
          <city>Leiden</city>
          <zip>2333 ZT</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <phone>31715263459</phone>
      </contact>
      <investigator>
        <last_name>Hans Gelderblom</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Temozolomide</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
      <mesh_term>Docetaxel</mesh_term>
      <mesh_term>Irinotecan</mesh_term>
      <mesh_term>Vinorelbine</mesh_term>
      <mesh_term>Ramucirumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
      <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
      <ipd_url>http://vivli.org/</ipd_url>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>September 26, 2019</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT05999994/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999994
  org study id: 17304
  secondary id: J1S-MC-JAAA
  nct id: NCT05999994
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The main purpose of the master is to help the research sites and sponsor carry out several
        clinical trials more efficiently by providing a common research protocol. Individual clinical
        trials under this master protocol define drug/disease-specific research goals and activities
        to test them. New studies will be added as new drugs emerge against different cancers.
        Participation in the trial will depend on how long the benefit lasts.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants Allocated to Each ISA
  time frame: Baseline up to Week 4
  description: Number of Participants Allocated to Each ISA
  arm group label: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
  arm group type: Experimental
  description: Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
  arm group label: Cyclophosphamide + Vinorelbine (DSRCT ISA)
  arm group type: Active Comparator
  description: Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
  arm group label: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
  arm group type: Experimental
  description: Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
  arm group label: Gemcitabine + Docetaxel (SS ISA)
  arm group type: Active Comparator
  description: Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
  arm group label: Abemaciclib + Irinotecan + Temozolomide (ES ISA)
  arm group type: Experimental
  description: Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
  arm group label: Irinotecan + Temozolomide (ES ISA)
  arm group type: Active Comparator
  description: Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
  intervention type: Drug
  intervention name: Ramucirumab
  description: Administered IV
  arm group label: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
  arm group label: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
  other name: LY3009806
  intervention type: Drug
  intervention name: Cyclophosphamide
  description: Administered orally
  arm group label: Cyclophosphamide + Vinorelbine (DSRCT ISA)
  arm group label: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
  intervention type: Drug
  intervention name: Vinorelbine
  description: Administered IV
  arm group label: Cyclophosphamide + Vinorelbine (DSRCT ISA)
  arm group label: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
  intervention type: Drug
  intervention name: Gemcitabine
  description: Administered IV
  arm group label: Gemcitabine + Docetaxel (SS ISA)
  arm group label: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
  other name: LY188011
  intervention type: Drug
  intervention name: Docetaxel
  description: Administered IV
  arm group label: Gemcitabine + Docetaxel (SS ISA)
  arm group label: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
  intervention type: Drug
  intervention name: Abemaciclib
  description: Administered orally
  arm group label: Abemaciclib + Irinotecan + Temozolomide (ES ISA)
  other name: LY2835219
  intervention type: Drug
  intervention name: Irinotecan
  description: Administered IV
  arm group label: Abemaciclib + Irinotecan + Temozolomide (ES ISA)
  arm group label: Irinotecan + Temozolomide (ES ISA)
  intervention type: Drug
  intervention name: Temozolomide
  description: Administered orally
  arm group label: Abemaciclib + Irinotecan + Temozolomide (ES ISA)
  arm group label: Irinotecan + Temozolomide (ES ISA)
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 39 Years
  healthy volunteers: No
  last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 Eastern time (UTC/GMT - 5 hours, EST)
  role: Study Director
  affiliation: Eli Lilly and Company
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: Clinicaltrials.gov@lilly.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Cyclophosphamide
  mesh term: Temozolomide
  mesh term: Gemcitabine
  mesh term: Docetaxel
  mesh term: Irinotecan
  mesh term: Vinorelbine
  mesh term: Ramucirumab
  sharing ipd: Yes
  ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
  ipd info type: Study Protocol
  ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
  ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
  ipd url: http://vivli.org/
  provided document: 