RecruitingPhase 2NCT04641247

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


Sponsor

GlaxoSmithKline

Enrollment

30 participants

Start Date

Apr 16, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term extension study for participants who are already receiving niraparib — a PARP inhibitor drug used to treat certain ovarian and other cancers — in a GlaxoSmithKline/TESARO-sponsored clinical trial, and who are continuing to benefit from treatment. It allows them to keep receiving niraparib after their original study ends. **You may be eligible if...** - You are currently enrolled in and benefiting from a GlaxoSmithKline/TESARO-sponsored niraparib study - Your primary study has completed its main objective - You are able and willing to continue study visits and follow the protocol - If you are able to become pregnant, you must agree to use effective contraception **You may NOT be eligible if...** - You were permanently stopped from taking niraparib in the original study - You have ongoing unresolved side effects from niraparib that required a treatment pause - You are pregnant, planning pregnancy, or breastfeeding during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib

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

View Full Details on ClinicalTrials.gov

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NCT04641247


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