NCT04641247RecruitingPhase 2
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 20 Nov 2020
- Start date
- 16 Apr 2021
- Primary completion date
- 28 Dec 2026
- Lead sponsor
- GlaxoSmithKline
- NCT number
- NCT04641247
- EU CT number
- 2023-506618-29-00
- EudraCT number
- 2020-002667-53
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 16 Apr 2021 to the primary completion date, 28 Dec 2026
- 27 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.