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NCT02655016 · ClinicalTrials.gov registry record · Phase 3
A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
A Phase 3 study of Ovarian Neoplasms, sponsored by Tesaro.
- Active
- Registry status
- Phase 3
- Development phase
- 733
- Enrollment target
- 20
- Study locations
NCT02655016: Active Phase 3 study of Ovarian Neoplasms, sponsored by Tesaro.
NCT02655016 is a Phase 3 study of Ovarian Neoplasms that is active but no longer recruiting, run by Tesaro. The registered enrollment target is 733 participants, above the 349-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02655016, a Phase 3 study of Ovarian Neoplasms, is active but no longer recruiting, sponsored by Tesaro.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 733 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Niraparib
Study Locations (20)
Arizona
- GSK Investigational Site - Tempe
- GSK Investigational Site - Tucson
- GSK Investigational Site - Tucson
California
- GSK Investigational Site - San Francisco
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Santa Rosa
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Miami
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Savannah
Indiana
- GSK Investigational Site - Indianapolis
- GSK Investigational Site - Indianapolis
Louisiana
- GSK Investigational Site - Covington
- GSK Investigational Site - New Orleans
Maryland
- GSK Investigational Site - Baltimore
- GSK Investigational Site - Rockville
Connecticut
- GSK Investigational Site - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 733 participants |
| Start Date | 2016-07-11 |
| Est. Completion | 2026-05-29 |
| Phase | Phase 3 |
What the registry record for NCT02655016 still lists
NCT02655016 is an interventional study that assigns participants to a tested intervention. The registered 733 participants enrollment target is mid-sized for trials with a published cap, above the 349-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (110% higher).
The record links to 1 condition, with Ovarian Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02655016 names 20 study sites across 11 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT02655016 about?
NCT02655016 is a clinical study titled "A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy". 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 me...
What is the current status of trial NCT02655016?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 733 participants. The study started on 2016-07-11. Estimated completion is 2026-05-29.
What conditions does trial NCT02655016 study?
This clinical trial studies the following conditions: Ovarian Neoplasms.
What interventions are being tested in trial NCT02655016?
The interventions under investigation include: Placebo (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT02655016?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02655016 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02655016's enrollment target sits among peer trials
733 8th of 38 higher than 31 of 38 other Ovarian Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
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A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.
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