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RECRUITING
NCT04641247
PHASE2

A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

Interventions

DRUG

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