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NCT04641247PHASE2Recruiting

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

GlaxoSmithKline

Start Date

4/16/2021

Completion Date

12/28/2026

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 Criteria

Age Range: 18 years to No maximum

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 study protocol requirements. * Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug. Exclusion Criteria: * Participant has been permanently discontinued from niraparib treatment in the parent study for any reason. * Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. * Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).

Interventions

DRUG

Niraparib

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Conditions

Ovarian NeoplasmsBreast Neoplasms

Locations

GSK Investigational Site

Tucson, Arizona 85710

United States

GSK Investigational Site

Encinitas, California 92024

United States

GSK Investigational Site

Los Angeles, California 90048

United States

GSK Investigational Site

Whittier, California 90603

United States

GSK Investigational Site

Jacksonville, Florida 32224

United States

GSK Investigational Site

Atlanta, Georgia 30342

United States

GSK Investigational Site

Harvey, Illinois 60426

United States

GSK Investigational Site

Boston, Massachusetts 02115

United States

GSK Investigational Site

Grand Rapids, Michigan 60637-1470

United States

GSK Investigational Site

Morristown, New Jersey 07962-1956

United States

GSK Investigational Site

Lake Success, New York 11042

United States

GSK Investigational Site

Charlotte, North Carolina 28204

United States

GSK Investigational Site

Cleveland, Ohio 44195

United States

GSK Investigational Site

Graz, A-8036

Austria

GSK Investigational Site

Vienna, 1090

Austria

GSK Investigational Site

Kelowna, British Columbia V5Z 4E6

Canada

GSK Investigational Site

Toronto, Ontario M5G 2M9

Canada

GSK Investigational Site

Montreal, Quebec H4A 3J1

Canada

GSK Investigational Site

Odense C, 5000

Denmark

GSK Investigational Site

Nantes, 44202

France

GSK Investigational Site

Nice, 06189

France

GSK Investigational Site

Haifa, 3109601

Israel

GSK Investigational Site

Cremona, 26100

Italy

GSK Investigational Site

Madrid, 28040

Spain

GSK Investigational Site

Madrid, 28046

Spain