Actively Recruiting
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
Led by GlaxoSmithKline · Updated on 2025-09-29
30
Participants Needed
25
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
GSK Investigational Site
Tucson, Arizona, United States, 85710
Completed
2
GSK Investigational Site
Encinitas, California, United States, 92024
Actively Recruiting
3
GSK Investigational Site
Los Angeles, California, United States, 90048
Actively Recruiting
4
GSK Investigational Site
Whittier, California, United States, 90603
Completed
5
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Completed
6
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
GSK Investigational Site
Harvey, Illinois, United States, 60426
Actively Recruiting
8
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
GSK Investigational Site
Grand Rapids, Michigan, United States, 60637-1470
Actively Recruiting
10
GSK Investigational Site
Morristown, New Jersey, United States, 07962-1956
Actively Recruiting
11
GSK Investigational Site
Lake Success, New York, United States, 11042
Actively Recruiting
12
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
13
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Completed
14
GSK Investigational Site
Graz, Austria, A-8036
Actively Recruiting
15
GSK Investigational Site
Vienna, Austria, 1090
Actively Recruiting
16
GSK Investigational Site
Kelowna, British Columbia, Canada, V5Z 4E6
Actively Recruiting
17
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
18
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
19
GSK Investigational Site
Odense C, Denmark, 5000
Completed
20
GSK Investigational Site
Nantes, France, 44202
Actively Recruiting
21
GSK Investigational Site
Nice, France, 06189
Completed
22
GSK Investigational Site
Haifa, Israel, 3109601
Actively Recruiting
23
GSK Investigational Site
Cremona, Italy, 26100
Actively Recruiting
24
GSK Investigational Site
Madrid, Spain, 28040
Actively Recruiting
25
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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