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A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Not Recruiting
Trial ID: NCT01847274
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. 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).
Official Title
A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Stanford Investigator(s)
Jonathan S. Berek, MD, MMSc
Laurie Kraus Lacob Professor
Oliver Dorigo, M.D., Ph.D.
Mary Lake Polan Professor
Eligibility
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
Intervention(s):
drug: placebo
drug: Active comparator: Niraparib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061