Status:
RECRUITING
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Ovarian Neoplasms
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wit...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 13 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04641247
Start Date
April 16 2021
End Date
November 13 2026
Last Update
September 29 2025
Active Locations (25)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85710
2
GSK Investigational Site
Encinitas, California, United States, 92024
3
GSK Investigational Site
Los Angeles, California, United States, 90048
4
GSK Investigational Site
Whittier, California, United States, 90603