A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01847274 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-333


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. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Ursula Matulonis, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Christina Herold, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

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 0-2 - 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
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