A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Trial Status: Closed to Accrual
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).
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 responded 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
California
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
Connecticut
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Florida
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Illinois
Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Indiana
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Iowa
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Maryland
Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Christina Isabella Herold
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Minnesota
Minneapolis
University of Minnesota / Masonic Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
North Carolina
Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Trial Phase Phase III
Trial Type Treatment
Lead Organization
Tesaro Inc
- Primary ID 213356
- Secondary IDs NCI-2013-02221, S13-00111, PR-30-5011-C
- Clinicaltrials.gov ID NCT01847274