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A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT02655016 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02655016
The ClinicalTrials.gov registry entry for NCT02655016 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 733 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02655016 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02655016?
The interventions under investigation include: Placebo (DRUG), Niraparib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02655016?
This trial is sponsored by Tesaro, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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