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A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2021-04-16
Completion Date
2026-11-13
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
Niraparib
Niraparib tablets or capsules will be given once a day via the oral route.
Locations (25)
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Encinitas, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Whittier, California, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Harvey, Illinois, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Grand Rapids, Michigan, United States
GSK Investigational Site
Morristown, New Jersey, United States
GSK Investigational Site
Lake Success, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Graz, Austria
GSK Investigational Site
Vienna, Austria
GSK Investigational Site
Kelowna, British Columbia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Odense C, Denmark
GSK Investigational Site
Nantes, France
GSK Investigational Site
Nice, France
GSK Investigational Site
Haifa, Israel
GSK Investigational Site
Cremona, Italy
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain