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Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Primary Purpose

Recurrent Ovarian Cancer

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Niraparib
Sponsored by
Tesaro, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Recurrent Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Female

Inclusion Criteria:

  1. Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  2. Completion of at least 2 previous courses of platinum-containing chemotherapy.
  3. Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy
  4. Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]
  5. Patients previously treated with PARP inhibitors are eligible
  6. Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1
  7. Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL]
  8. Able to take oral medications
  9. Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib
  10. Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy

Exclusion Criteria:

  1. Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
  2. Known hypersensitivity to the components of niraparib
  3. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
  4. Patient has uncontrolled hypertension

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 16, 2017
    Last Updated
    April 13, 2017
    Sponsor
    Tesaro, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03025867
    Brief Title
    Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
    Official Title
    Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tesaro, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Ovarian Cancer

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Niraparib

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer Completion of at least 2 previous courses of platinum-containing chemotherapy. Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles] Patients previously treated with PARP inhibitors are eligible Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1 Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL] Able to take oral medications Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy Exclusion Criteria: Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy Known hypersensitivity to the components of niraparib Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment Patient has uncontrolled hypertension

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

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