Trials / Completed
CompletedNCT01847274
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 596 (actual)
- Sponsor
- Tesaro, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Active comparator: Niraparib | Niraparib vs placebo 2:1 ratio |
| DRUG | placebo |
Timeline
- Start date
- 2013-06-21
- Primary completion
- 2016-04-22
- Completion
- 2021-12-26
- First posted
- 2013-05-06
- Last updated
- 2023-06-02
- Results posted
- 2019-05-01
Locations
112 sites across 15 countries: United States, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01847274. Inclusion in this directory is not an endorsement.