A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Completed · Phase 3 · Has a placebo group
Conditions studied: Ovarian Neoplasms, Platinum Sensitive Ovarian Cancer
In brief
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).
Key facts
- Study ID
- NCT01847274
- Run by
- Tesaro, Inc.
- People needed
- 596
- Starts
- 2013-06-21
- Expected to finish
- 2021-12-26
- Last updated by the study team
- 2023-06-02
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- GSK Investigational Site — Tucson, Arizona, United States
- GSK Investigational Site — Los Angeles, California, United States
- GSK Investigational Site — Los Angeles, California, United States
- GSK Investigational Site — Palo Alto, California, United States
- GSK Investigational Site — San Francisco, California, United States
- GSK Investigational Site — New Haven, Connecticut, United States
- GSK Investigational Site — Sarasota, Florida, United States
- GSK Investigational Site — Tampa, Florida, United States
- GSK Investigational Site — Atlanta, Georgia, United States
- GSK Investigational Site — Chicago, Illinois, United States
- GSK Investigational Site — Indianapolis, Indiana, United States
- GSK Investigational Site — Indianapolis, Indiana, United States
- GSK Investigational Site — Boston, Massachusetts, United States
- GSK Investigational Site — Boston, Massachusetts, United States
- GSK Investigational Site — Burlington, Massachusetts, United States
- GSK Investigational Site — Minneapolis, Minnesota, United States
- GSK Investigational Site — Minneapolis, Minnesota, United States
- GSK Investigational Site — Rochester, Minnesota, United States
- GSK Investigational Site — Morristown, New Jersey, United States
- GSK Investigational Site — Farmington, New Mexico, United States
- GSK Investigational Site — Lake Success, New York, United States
- GSK Investigational Site — New York, New York, United States
- GSK Investigational Site — New York, New York, United States
- GSK Investigational Site — Durham, North Carolina, United States
- GSK Investigational Site — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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