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RecruitingInterventionalPhase 2

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

NCT ID: NCT04641247Sponsor: GlaxoSmithKlineLast updated: 2025-09-29

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.

Arms & interventions

  • DrugNiraparib

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

Outcome measures

Primary

  • Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

    AEs, SAEs and AESI will be collected.

    Time frame: Up to 5 years

  • Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status

    The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Number of participants with clinically significant changes in ECOG performance status will be summarized.

    Time frame: Up to 5 years

  • Number of participants with clinically significant changes in hematology and clinical chemistry parameters

    Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.

    Time frame: Up to 5 years

  • Number of participants with clinically significant changes in vital signs

    Number of participants with clinically significant changes in vital signs will be assessed.

    Time frame: Up to 5 years

  • Number of participants with clinically significant changes in physical examination

    Number of participants with clinically significant changes in physical examination will be assessed.

    Time frame: Up to 5 years

  • Number of participants with use of concomitant medications

    Number of participants using concomitant medications will be assessed.

    Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (13)

GSK Investigational Site

Tucson, Arizona, 85710

Completed

GSK Investigational Site

Encinitas, California, 92024

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Alberto Bessudo · Principal Investigator

GSK Investigational Site

Los Angeles, California, 90048

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Bobbie Rimel · Principal Investigator

GSK Investigational Site

Whittier, California, 90603

Completed

GSK Investigational Site

Jacksonville, Florida, 32224

Completed

GSK Investigational Site

Atlanta, Georgia, 30342

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Meaghan Tenney · Principal Investigator

GSK Investigational Site

Harvey, Illinois, 60426

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Ivy Abraham · Principal Investigator

GSK Investigational Site

Boston, Massachusetts, 02115

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Wendy Y Chen · Principal Investigator

GSK Investigational Site

Grand Rapids, Michigan, 60637-1470

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Manish Sharma · Principal Investigator

GSK Investigational Site

Morristown, New Jersey, 07962-1956

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Nana Eleonore Tchabo · Principal Investigator

GSK Investigational Site

Lake Success, New York, 11042

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Veena John · Principal Investigator

GSK Investigational Site

Charlotte, North Carolina, 28204

Recruiting
US GSK Clinical Trials Call Center · Contact
EU GSK Clinical Trials Call Centre · Contact
Antoinette Tan · Principal Investigator

GSK Investigational Site

Cleveland, Ohio, 44195

Completed