Recruiting

Phase 2

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

Sponsor:

GlaxoSmithKline

Code:

NCT04641247

Conditions

Ovarian Neoplasms

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Niraparib

Study Details

Brief summary:

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.

Conditions

Ovarian Neoplasms

Breast Neoplasms

Study ID

NCT04641247

Start date

Apr 16, 2021

Status verified date

Jun, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Dec 28, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

37 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving niraparib

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.

Interventions

Niraparib

Niraparib tablets or capsules will be given once a day via the oral route.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Encinitas, California, United States, 92024

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Alberto Bessudo

GSK Investigational Site

Recruiting

Los Angeles, California, United States, 90048

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Bobbie Rimel

GSK Investigational Site

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Meaghan Tenney

GSK Investigational Site

Recruiting

Harvey, Illinois, United States, 60426

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ivy Abraham

GSK Investigational Site

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Heather Parsons

GSK Investigational Site

Recruiting

Grand Rapids, Michigan, United States, 60637-1470

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Manish Sharma

GSK Investigational Site

Recruiting

Morristown, New Jersey, United States, 07962-1956

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nana Tchabo

GSK Investigational Site

Recruiting

Lake Success, New York, United States, 11042

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Veena John

GSK Investigational Site

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Antoinette Tan

GSK Investigational Site

Recruiting

Kelowna, British Columbia, Canada, V5Z 4E6

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Anna Tinker

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Amit Oza

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Lucy Gilbert

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

Adverse events
Open-label extension
Parent study
Niraparib
Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-06-24.