Trials / Active Not Recruiting
Active Not RecruitingNCT02655016
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 733 (actual)
- Sponsor
- Tesaro, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Niraparib will be administered. |
| DRUG | Placebo | Placebo will be administered. |
Timeline
- Start date
- 2016-07-11
- Primary completion
- 2019-05-17
- Completion
- 2026-05-29
- First posted
- 2016-01-13
- Last updated
- 2026-03-10
- Results posted
- 2020-06-11
Locations
116 sites across 14 countries: United States, Belgium, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02655016. Inclusion in this directory is not an endorsement.