Expanded Access Program for Niraparib in Patients with Recurrent Ovarian Cancer

Sponsor: Tesaro, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03025867

Provider View

This program provides access to the drug niraparib for patients with recurrent ovarian cancer before it is approved by the FDA. It is for those who have responded well to recent platinum-based chemotherapy treatments.

Patient Parameters

Program Overview

This expanded access program allows patients with recurrent ovarian cancer to receive the drug niraparib before it is officially approved by the FDA. To qualify, patients must have shown a partial or complete response to their most recent platinum-based chemotherapy and also to the one before that, with no disease progression for at least six months after the penultimate treatment.

Description

Patients who are eligible for ongoing niraparib clinical trials or are already participating in one cannot join this expanded access program. Current niraparib trials include:

  • A Phase 3 trial for patients who have had first-line treatment for ovarian cancer (PRIMA trial, NCT # 02655016)
  • A Phase 2 trial for patients who have had multiple treatments for ovarian cancer (QUADRA trial, NCT # 02354586)
  • A Phase 1/2 trial for patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer (TOPACIO trial, NCT # 02657889)

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
  • Completed at least two courses of platinum-based chemotherapy
  • Had a partial or complete response lasting at least six months after the second-to-last chemotherapy
  • Achieved a partial or complete response after the last platinum-based chemotherapy (at least four cycles)
  • Previously treated with PARP inhibitors are eligible
  • Good overall health with an ECOG performance status of 0 or 1
  • Adequate organ function (specific blood counts and hemoglobin levels)
  • Able to take oral medications
  • Not pregnant and agree not to become pregnant while on niraparib
  • Start niraparib treatment within 12 weeks after the last dose of platinum-based chemotherapy

Exclusion Criteria

  • Ongoing significant blood-related side effects from previous cancer treatment
  • Known allergy to niraparib components
  • Pregnant or breastfeeding, or planning to become pregnant during the program
  • Uncontrolled high blood pressure

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