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
GlaxoSmithKline
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent. * Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. * Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective. * Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent…
Interventions
- DrugNiraparib
Niraparib tablets or capsules will be given once a day via the oral route.
Locations (25)
- GSK Investigational SiteTucson, Arizona
- GSK Investigational SiteEncinitas, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteWhittier, California
- GSK Investigational SiteJacksonville, Florida
- GSK Investigational SiteAtlanta, Georgia