Actively Recruiting
Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO Niraparib Study and May Benefit from Continued Treatment
Led by GlaxoSmithKline · Updated on 2025-09-29
30
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to provide continued access to the drug niraparib and further understand its long-term safety in participants who are currently being treated with niraparib in previous GlaxoSmithKline/TESARO-sponsored studies that have completed their main goals. The study includes adults with ovarian or breast cancers who are benefiting from niraparib treatment as judged by their doctor. Participants will take niraparib once daily by mouth continuously in 90-day cycles. The dose will be the same as what they received in their prior study. They will continue treatment until disease progression, unacceptable side effects, starting a new anticancer therapy not part of the previous study, withdrawal of consent, or other reasons decided by the doctor or participant. During the study, participants will attend scheduled visits where researchers will monitor side effects, physical health including vital signs and physical exams, lab tests, and overall wellbeing up to five years. They will track adverse events, changes in performance status, blood tests, and use of other medications. This long-term follow-up helps collect important safety information while participants continue niraparib treatment under medical supervision.
CONDITIONS
Brief 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...
- Able to understand study procedures and provide written informed consent
- Willing and able to follow study visits, treatment plans, and procedures
- Currently receiving niraparib treatment in a prior GlaxoSmithKline/TESARO-sponsored study that completed its main objectives
- Currently benefiting from niraparib treatment as assessed by the investigator
- Participants of childbearing potential and their partners agree to use effective contraception during treatment and for 180 days after last dose
You will not qualify if you...
- Permanently stopped niraparib treatment in the prior study for any reason
- Currently have unresolved side effects that interrupted niraparib dosing in the prior study (may enroll once resolved and treatment can resume)
- Pregnant or expecting to conceive during treatment or for 180 days after last dose
- Breastfeeding or expecting to breastfeed within 30 days after last dose; women must not breastfeed or store breastmilk during treatment and 30 days after final dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants receive niraparib once daily in repeated 90-day cycles until disease progression, unacceptable toxicity, or other criteria for discontinuation are met.
Regular visits throughout treatment as determined by the investigator
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
E
EU GSK Clinical Trials Call Center
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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