Last updated: 09/26/2025 16:00:35
A long-term treatment extension study of niraparib in participants who completed a prior GlaxoSmithKline/TESARO-sponsored niraparib study
GSK study ID
213409
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and are Judged by the Investigator to Benefit from Continued Treatment with Niraparib
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
Timeframe: Up to 5 years
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
Timeframe: Up to 5 years
Number of participants with clinically significant changes in hematology and clinical chemistry parameters
Timeframe: Up to 5 years
Number of participants with clinically significant changes in vital signs
Timeframe: Up to 5 years
Number of participants with clinically significant changes in physical examination
Timeframe: Up to 5 years
Number of participants with use of concomitant medications
Timeframe: Up to 5 years
Secondary outcomes:
Not applicable
Interventions:
Drug: Niraparib
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
2026-13-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Ovarian Neoplasms, Breast Neoplasms
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2021 to November 2026
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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 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.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Jacksonville, FL, United States, 32224
Status
Study Complete
Location
GSK Investigational Site
Grand Rapids, MI, United States, 60637-1470
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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