Trials / Recruiting
RecruitingNCT04641247
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Niraparib tablets or capsules will be given once a day via the oral route. |
Timeline
- Start date
- 2021-04-16
- Primary completion
- 2026-11-13
- Completion
- 2026-11-13
- First posted
- 2020-11-23
- Last updated
- 2025-09-29
Locations
25 sites across 8 countries: United States, Austria, Canada, Denmark, France, Israel, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04641247. Inclusion in this directory is not an endorsement.