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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 is a Phase 3 study that has completed, run by Tesaro. The registered enrollment target is 596 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01847274
The ClinicalTrials.gov registry entry for NCT01847274 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 596 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01847274 reports 0 study locations.
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.
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