<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/NCT03025867</url>
  </required_header>
  <id_info>
    <org_study_id>3000-07-001</org_study_id>
    <nct_id>NCT03025867</nct_id>
  </id_info>
  <brief_title>Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer</brief_title>
  <official_title>Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tesaro, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tesaro, Inc.</source>
  <brief_summary>
    <textblock>
      This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.&#xD;
&#xD;
      This program is designed to provide access to niraparib prior to approval by the US Food and&#xD;
      Drug Administration (FDA).&#xD;
&#xD;
      To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete&#xD;
      response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR&#xD;
      or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months&#xD;
      without disease progression after this chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If a patient qualifies for participation in an ongoing niraparib clinical trial or is already&#xD;
      participating in a niraparib clinical trial, she will not be able to participate in the EAP.&#xD;
&#xD;
      Ongoing clinical trials for niraparib include:&#xD;
&#xD;
        -  A Phase 3 trial in patients who have received first-line treatment for ovarian cancer&#xD;
           (the PRIMA trial, NCT # 02655016)&#xD;
&#xD;
        -  A Phase 2 trial in patients who have received multiple lines of treatment for ovarian&#xD;
           cancer (the QUADRA trial, NCT # 02354586)&#xD;
&#xD;
        -  A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer&#xD;
           or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Approved for marketing</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Recurrent Ovarian Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal&#xD;
             cancer&#xD;
&#xD;
          2. Completion of at least 2 previous courses of platinum-containing chemotherapy.&#xD;
&#xD;
          3. Had a CR or PR with duration of response &gt;/=6 months following penultimate&#xD;
             chemotherapy&#xD;
&#xD;
          4. Achieved a partial (PR) or complete (CR) tumor response following completion of the&#xD;
             last platinum-containing chemotherapy [minimum of 4 cycles]&#xD;
&#xD;
          5. Patients previously treated with PARP inhibitors are eligible&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0&#xD;
             or 1&#xD;
&#xD;
          7. Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to)&#xD;
             1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater&#xD;
             than or equal to) 9 g/dL]&#xD;
&#xD;
          8. Able to take oral medications&#xD;
&#xD;
          9. Women should not be pregnant at the beginning of the treatment and women or&#xD;
             childbearing potential should not become pregnant while on niraparib&#xD;
&#xD;
         10. Patient should start treatment with niraparib no later than 12 weeks after completion&#xD;
             of final dose of the platinum-containing chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy&#xD;
&#xD;
          2. Known hypersensitivity to the components of niraparib&#xD;
&#xD;
          3. Patient is pregnant or breast feeding, or expecting to conceive children within the&#xD;
             projected duration of the program treatment&#xD;
&#xD;
          4. Patient has uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>April 2017</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 20, 2017</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niraparib</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/NCT03025867
org study id: 3000-07-001
nct id: NCT03025867
lead sponsor: 
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.

      This program is designed to provide access to niraparib prior to approval by the US Food and
      Drug Administration (FDA).

      To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete
      response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR
      or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months
      without disease progression after this chemotherapy.
If a patient qualifies for participation in an ongoing niraparib clinical trial or is already
      participating in a niraparib clinical trial, she will not be able to participate in the EAP.

      Ongoing clinical trials for niraparib include:

        -  A Phase 3 trial in patients who have received first-line treatment for ovarian cancer
           (the PRIMA trial, NCT # 02655016)

        -  A Phase 2 trial in patients who have received multiple lines of treatment for ovarian
           cancer (the QUADRA trial, NCT # 02354586)

        -  A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer
           or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)
intervention type: Drug
intervention name: Niraparib
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Recurrence
mesh term: Niraparib