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NCT01847274 · ClinicalTrials.gov registry record · Phase 3
A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
A Phase 3 study, sponsored by Tesaro.
- Completed
- Registry status
- Phase 3
- Development phase
- 596
- Enrollment target
NCT01847274: Completed Phase 3 study, sponsored by Tesaro.
NCT01847274 is a Phase 3 study that has completed, run by Tesaro. The registered enrollment target is 596 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01847274, a Phase 3 study, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 596 participants
- Enrollment target
Study 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).
Primary Outcome
PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was
Interventions
- DRUG placebo
- DRUG Active comparator: Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 596 participants |
| Start Date | 2013-06-21 |
| Est. Completion | 2021-12-26 |
| Phase | Phase 3 |
What the finished NCT01847274 record still lists
NCT01847274 is an interventional study that assigns participants to a tested intervention. The registered 596 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01847274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01847274 about?
NCT01847274 is a clinical study titled "A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer". 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 plat...
What is the current status of trial NCT01847274?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 596 participants. The study started on 2013-06-21. Estimated completion is 2021-12-26.
What interventions are being tested in trial NCT01847274?
The interventions under investigation include: placebo (DRUG), Active comparator: Niraparib (DRUG).
Who is sponsoring clinical trial NCT01847274?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01847274's enrollment target sits among peer trials
596 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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