A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Public ClinicalTrials.gov record NCT02354586. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02354586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 463 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 23, 2015 (Actual)
- Primary completion
- Feb 28, 2018 (Actual)
- Completion
- Aug 23, 2021 (Actual)
- Last update posted
- Sep 15, 2022
2015 – 2021
United States locations
- U.S. sites
- 48
- U.S. states
- 23
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | 85224 | — |
| GSK Investigational Site | Phoenix | Arizona | 85016 | — |
| GSK Investigational Site | Tucson | Arizona | 85710 | — |
| GSK Investigational Site | Burbank | California | 91505 | — |
| GSK Investigational Site | Duarte | California | 91010 | — |
| GSK Investigational Site | Los Angeles | California | 90027 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | San Francisco | California | 94118 | — |
| GSK Investigational Site | Santa Barbara | California | 93105 | — |
| GSK Investigational Site | Stanford | California | 94305-5317 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Tampa | Florida | 33612 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Chicago | Illinois | 60637 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | — |
| GSK Investigational Site | Indianapolis | Indiana | 54244 | — |
| GSK Investigational Site | Covington | Louisiana | 70433 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70121 | — |
| GSK Investigational Site | Baltimore | Maryland | 21202 | — |
| GSK Investigational Site | Boston | Massachusetts | 02115 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Burlington | Massachusetts | 01805 | — |
| GSK Investigational Site | Ann Arbor | Michigan | 48109 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | — |
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | Springfield | Missouri | 65804 | — |
| GSK Investigational Site | Hackensack | New Jersey | 07601 | — |
| GSK Investigational Site | Morristown | New Jersey | 07962-1956 | — |
| GSK Investigational Site | East Setauket | New York | 11733 | — |
| GSK Investigational Site | Jamaica | New York | 11432 | — |
| GSK Investigational Site | Lake Success | New York | 11042 | — |
| GSK Investigational Site | New York | New York | 10065 | — |
| GSK Investigational Site | Durham | North Carolina | 27710 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| GSK Investigational Site | Medford | Oregon | 97504-8342 | — |
| GSK Investigational Site | Wynnewood | Pennsylvania | 19096 | — |
| GSK Investigational Site | Providence | Rhode Island | 02905 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Austin | Texas | 78731 | — |
| GSK Investigational Site | Dallas | Texas | 75390 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | The Woodlands | Texas | 77380 | — |
| GSK Investigational Site | Tyler | Texas | 75702 | — |
| GSK Investigational Site | Spokane | Washington | 99202 | — |
| GSK Investigational Site | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02354586, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2022 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02354586 live on ClinicalTrials.gov.