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NCT02354586 · ClinicalTrials.gov registry record · Phase 2
A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
A Phase 2 study of Ovarian Cancer and Ovarian Neoplasms, sponsored by Tesaro.
- Completed
- Registry status
- Phase 2
- Development phase
- 463
- Enrollment target
- 20
- Study locations
NCT02354586 is a Phase 2 study of Ovarian Cancer and Ovarian Neoplasms that has completed, run by Tesaro. The registered enrollment target is 463 participants, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT02354586, a Phase 2 study of Ovarian Cancer and Ovarian Neoplasms, has completed, sponsored by Tesaro.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 463 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.
Conditions Studied
Interventions
- DRUG Niraparib
Study Locations (20)
California
- GSK Investigational Site - Burbank
- GSK Investigational Site - Duarte
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Santa Barbara
- GSK Investigational Site - Stanford
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
Florida
- GSK Investigational Site - Tampa
- GSK Investigational Site - West Palm Beach
Illinois
- GSK Investigational Site - Chicago
- GSK Investigational Site - Chicago
Indiana
- GSK Investigational Site - Indianapolis
- GSK Investigational Site - Indianapolis
Louisiana
- GSK Investigational Site - Covington
- GSK Investigational Site - New Orleans
Connecticut
- GSK Investigational Site - New Haven
Georgia
- GSK Investigational Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2015-03-23 |
| Est. Completion | 2021-08-23 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02354586
The ClinicalTrials.gov registry entry for NCT02354586 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (36% lower). The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which Niraparib is the first listed.
NCT02354586 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT02354586 about?
NCT02354586 is a clinical study titled "A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens". This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28...
What is the current status of trial NCT02354586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 463 participants. The study started on 2015-03-23. Estimated completion is 2021-08-23.
What conditions does trial NCT02354586 study?
This clinical trial studies the following conditions: Ovarian Cancer, Ovarian Neoplasms.
What interventions are being tested in trial NCT02354586?
The interventions under investigation include: Niraparib (DRUG).
Who is sponsoring clinical trial NCT02354586?
This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02354586 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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Related
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