A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Public ClinicalTrials.gov record NCT03326193. 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, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Niraparib Combined With Bevacizumab as Maintenance Treatment in Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Following Front-line Platinum-based Chemotherapy With Bevacizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Niraparib is an oral inhibitor of poly adenosine diphosphate-ribose polymerase (PARP)-1 and PARP-2. This study will evaluate safety and efficacy of niraparib combined with bevacizumab as maintenance treatment in participants with advanced (stage IIIB-IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following front-line platinum-based chemotherapy with bevacizumab. Eligible participants who achieve complete response (CR), partial response (PR), or no evidence of disease (NED) following treatment with platinum-based chemotherapy in addition to bevacizumab will be enrolled in the study and will receive maintenance treatment with niraparib (for up to 3 years) combined with bevacizumab (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first. Participants who have not progressed after 3 years of niraparib maintenance treatment may continue with niraparib beyond 3 years if they are benefiting from treatment, upon consultation with Sponsor.
Study identification
- NCT ID
- NCT03326193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 105 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
- Dec 12, 2017 (Actual)
- Primary completion
- Dec 24, 2020 (Actual)
- Completion
- Jul 12, 2024 (Actual)
- Last update posted
- Jul 31, 2025
2017 – 2024
United States locations
- U.S. sites
- 29
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36604 | — |
| GSK Investigational Site | Anchorage | Alaska | 99508 | — |
| GSK Investigational Site | Mesa | Arizona | 85284 | — |
| GSK Investigational Site | Burbank | California | 91505 | — |
| GSK Investigational Site | Los Angeles | California | 90095 | — |
| GSK Investigational Site | Fort Myers | Florida | 33908 | — |
| GSK Investigational Site | St. Petersburg | Florida | 33705 | — |
| GSK Investigational Site | Kansas City | Kansas | 66205 | — |
| GSK Investigational Site | Detroit | Michigan | 48201 | — |
| GSK Investigational Site | Detroit | Michigan | 48202 | — |
| GSK Investigational Site | Jackson | Mississippi | 39216 | — |
| GSK Investigational Site | Columbia | Missouri | 65212 | — |
| GSK Investigational Site | Kansas City | Missouri | 64132 | — |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | — |
| GSK Investigational Site | Englewood | New Jersey | 07631 | — |
| GSK Investigational Site | Morristown | New Jersey | 07962-1956 | — |
| GSK Investigational Site | Summit | New Jersey | 07962-1956 | — |
| GSK Investigational Site | Albany | New York | 12208 | — |
| GSK Investigational Site | Rochester | New York | 14642 | — |
| GSK Investigational Site | Asheville | North Carolina | 28816 | — |
| GSK Investigational Site | Columbus | Ohio | 43214 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | — |
| GSK Investigational Site | Providence | Rhode Island | 02905 | — |
| GSK Investigational Site | Chattanooga | Tennessee | 37403 | — |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03326193, 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 Jul 31, 2025 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03326193 live on ClinicalTrials.gov.