Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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).

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

26

Study ID:

NCT04641247

Recruitment Status:

Active, not recruiting

Sponsor:

GlaxoSmithKline

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There are 23 Locations for this study

See Locations Near You

GSK Investigational Site
Tucson Arizona, 85710, United States
GSK Investigational Site
West Hollywood 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
Morristown New Jersey, 07962, 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-803, Austria
GSK Investigational Site
Wien , 1090, Austria
GSK Investigational Site
Vancouver British Columbia, V5Z 4, Canada
GSK Investigational Site
Toronto Ontario, M5G 2, Canada
GSK Investigational Site
Montreal Quebec, H4A 3, Canada
GSK Investigational Site
Odense , 5000, Denmark
GSK Investigational Site
Nantes cedex , 44202, France
GSK Investigational Site
Nice Cedex 2 , 06189, France
GSK Investigational Site
Haifa , 31096, Israel
GSK Investigational Site
Cremona Lombardia, 26100, Italy
GSK Investigational Site
Madrid , 28046, Spain
GSK Investigational Site
Marid , 28040, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

26

Study ID:

NCT04641247

Recruitment Status:

Active, not recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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