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Long-term niraparib treatment for people who completed a prior GSK/TESARO niraparib protocol

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

PHASE2 · GlaxoSmithKline · NCT04641247

This extension lets people with ovarian or breast cancer who finished a GSK/TESARO niraparib protocol keep taking niraparib to see if it remains safe over the long term.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline (industry)
Locations25 sites (Tucson, Arizona and 24 other locations)
Trial IDNCT04641247 on ClinicalTrials.gov

What this trial studies

This open-label extension provides continued access to niraparib for participants who completed a GSK/TESARO-sponsored parent protocol and are still receiving benefit. Participants who meet entry requirements continue on niraparib and are followed for long-term safety and adverse events. The study enrolls adults previously treated with niraparib (monotherapy or combination) and requires informed consent and contraception use for those of childbearing potential. Data collected will characterize tolerability and safety signals with extended exposure to niraparib.

Who should consider this trial

Good fit: Ideal candidates are adults with ovarian or breast cancer currently receiving niraparib in a GlaxoSmithKline/TESARO-sponsored parent protocol who are judged by their investigator to be benefiting from treatment and who can meet consent and contraception requirements.

Not a fit: Patients who were permanently discontinued from niraparib in the parent protocol, who are not benefiting from niraparib, or who did not participate in a qualifying GSK/TESARO parent protocol are unlikely to receive benefit from this extension.

Why it matters

Potential benefit: If successful, participants may continue a therapy that is helping them while the study yields important data on the long-term safety of niraparib.

How similar studies have performed: PARP inhibitors including niraparib have demonstrated clinical benefit in ovarian cancer and extension programs have previously been used to monitor long-term safety, so this approach builds on established clinical experience.

Eligibility criteria

Show full inclusion / 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).

Where this trial is running

Tucson, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ovarian Neoplasms, Breast Neoplasms, Adverse events, Open-label extension, Parent study, Niraparib, Safety

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.