A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Public ClinicalTrials.gov record NCT01847274. 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 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01847274
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 596 participants
Conditions and interventions
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
- Jun 21, 2013 (Actual)
- Primary completion
- Apr 22, 2016 (Actual)
- Completion
- Dec 26, 2021 (Actual)
- Last update posted
- Jun 2, 2023
2013 – 2021
United States locations
- U.S. sites
- 35
- U.S. states
- 19
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85013 | — |
| GSK Investigational Site | Tucson | Arizona | 85704 | — |
| GSK Investigational Site | Los Angeles | California | 90027 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | Palo Alto | California | 94304 | — |
| GSK Investigational Site | San Francisco | California | 94109 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Sarasota | Florida | 34232 | — |
| GSK Investigational Site | Tampa | Florida | 33612 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46202 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | — |
| GSK Investigational Site | Boston | Massachusetts | 02115 | — |
| GSK Investigational Site | Boston | Massachusetts | 02215 | — |
| GSK Investigational Site | Burlington | Massachusetts | 01805 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | — |
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | Morristown | New Jersey | 07962-1956 | — |
| GSK Investigational Site | Farmington | New Mexico | 87401 | — |
| GSK Investigational Site | Lake Success | New York | 11042 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| 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 | Vancouver | Oregon | 98684 | — |
| GSK Investigational Site | Abington | Pennsylvania | 19001-3788 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | — |
| 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 | The Woodlands | Texas | 77380 | — |
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 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01847274, 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 Jun 2, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01847274 live on ClinicalTrials.gov.