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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: Completed Phase 2 study of Ovarian Cancer and Ovarian Neoplasms, sponsored by Tesaro.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis, PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Primary Analysis
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 |
What the finished NCT02354586 record still lists
NCT02354586 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, below the 727-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (36% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Where NCT02354586's enrollment target sits among peer trials
463 57th of 322 higher than 266 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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.
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