Continued niraparib treatment for people with ovarian, breast or prostate cancer
Tests continued niraparib in adults with advanced cancer who finished a prior study.
Key facts
- Who runs it
- GlaxoSmithKline
- Where
- Haifa, IsraelSee the siteAlso in 9 other countries, 26 sites
- Registry title
- A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 37 people, planned
- Started
- 16 Apr 2021
- Expected to end
- 28 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Niraparib
- Record updated
- 24 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are already taking niraparib in an earlier GlaxoSmithKline/TESARO study and whose doctor sees a benefit from continuing it.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Earlier treatment
- Must be taking niraparib now (alone or with other drugs) in an earlier GlaxoSmithKline/TESARO study that has met its main goal. The doctor must see a benefit from it.
Main reasons for not taking part
- Stopped niraparib for good in the earlier study, for any reason
- Unresolved side effects that paused niraparib in the earlier study
- Pregnant, or expecting to conceive during treatment or up to 180 days after the last dose
- Breastfeeding, or expecting to breastfeed within 30 days of the last dose
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Have you ever taken a PARP inhibitor (a tablet such as niraparib, olaparib or rucaparib) for your cancer?
Where in Israel
Also in 9 other countries, 26 sites
- HaifaHospital not named in the registryContact: Amnon Amit (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Participants receiving niraparibTreatment being tested
Participants will receive niraparib once a day, continuously throughout each 90-day cycle until one of the following occurs: disease progression, unacceptable toxicity, initiation of new anticancer therapy that was not part of the parent study, withdrawal of consent, discontinuation at the discretion of the Investigator, noncompliance with protocol, death, or discontinuation for any other reason. The doses provided in this long-term treatment extension study will be those defined in the parent study for each enrolled participant. The starting dose of niraparib will be the same as the assigned dose and regimen that were given in the parent study.
Treatment: Niraparib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Continued niraparib treatment for people with ovarian, breast or prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04641247, who can take part
- Record updated
- 24 June 2026