A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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).

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

niraparib tosylate monohydrate. An orally bioavailable, hydrated, tosylate salt form of niraparib, an inhibitor of poly (ADP-ribose) polymerase (PARP) types 1 and 2 (PARP-1 and -2), with antineoplastic activity. Upon administration, niraparib binds to and inhibits the activity of PARP-1 and -2, thereby inhibiting PARP-1 and -2-mediated DNA repair, enhancing the accumulation of DNA strand breaks, promoting genomic instability and resulting in apoptosis. The PARP family of proteins catalyzes post-translational ADP-ribosylation of nuclear proteins and is activated by single-strand DNA (ssDNA) breaks. NCI Drug Dictionary

Treatments listed in the registry

• Niraparib (Drug): Niraparib tablets or capsules will be given once a day via the oral route.

Na · Single Group · masking: None

Main goals

• Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) (Up to 5 years)
• Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status (Up to 5 years)
• Number of participants with clinically significant changes in hematology and clinical chemistry parameters (Up to 5 years)
• Number of participants with clinically significant changes in vital signs (Up to 5 years)
• Number of participants with clinically significant changes in physical examination (Up to 5 years)
• Number of participants with use of concomitant medications (Up to 5 years)

Planned enrollment: 37 (estimated).

• GSK Investigational Site, Encinitas, California
• GSK Investigational Site, Los Angeles, California
• GSK Investigational Site, Atlanta, Georgia
• GSK Investigational Site, Harvey, Illinois
• GSK Investigational Site, Boston, Massachusetts
• GSK Investigational Site, Grand Rapids, Michigan
• GSK Investigational Site, Morristown, New Jersey
• GSK Investigational Site, Lake Success, New York
• GSK Investigational Site, Charlotte, North Carolina

9 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT04641247
• NCI Drug Dictionary: C133238

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 23, 2026. Public record; not medical advice.