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A Phase III Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer

Conditions

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle.


Participation Guidelines

Age:
Gender:
Female

Eligibility Criteria

Inclusion Criteria:

  • 18 years of age or older, female, any race
  • Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
  • High grade (or grade 3) serous histology or known to have gBRCAmut
  • Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
  • Has response to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
  • ECOG 0-1
  • Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • Known hypersensitivity to the components of niraparib
  • Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
  • Symptomatic uncontrolled brain metastasis
  • Is pregnant or breast feeding
  • Immunocompromised patients
  • Known active hepatic disease
  • Prior treatment with a known PARP inhibitor
Sponsor:
TESARO, Inc
Dates:
03/25/2014
Last Updated:
Study HIC#:
1310012964