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

NCT04641247 · GlaxoSmithKline
In plain English

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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
About this study
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.
Eligibility 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).
Study design
Enrollment target: 37 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-04-16
Estimated completion: 2026-12-28
Last updated: 2026-06-24
Interventions
Drug: Niraparib
Primary outcomes
  • 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)
Sponsor
GlaxoSmithKline · industry
Contacts & investigators
ContactUS GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · 877-379-3718
ContactEU GSK Clinical Trials Call Center · contact · GSKClinicalSupportHD@gsk.com · +44 (0) 20 89904466
InvestigatorGSK Clinical Trials · study_director, GlaxoSmithKline
All locations (25)
GSK Investigational SiteCompleted
Tucson, Arizona, United States
GSK Investigational SiteRecruiting
Encinitas, California, United States
GSK Investigational SiteRecruiting
Los Angeles, California, United States
GSK Investigational SiteCompleted
Whittier, California, United States
GSK Investigational SiteCompleted
Jacksonville, Florida, United States
GSK Investigational SiteRecruiting
Atlanta, Georgia, United States
GSK Investigational SiteRecruiting
Harvey, Illinois, United States
GSK Investigational SiteRecruiting
Boston, Massachusetts, United States
GSK Investigational SiteRecruiting
Grand Rapids, Michigan, United States
GSK Investigational SiteRecruiting
Morristown, New Jersey, United States
GSK Investigational SiteRecruiting
Lake Success, New York, United States
GSK Investigational SiteRecruiting
Charlotte, North Carolina, United States
GSK Investigational SiteCompleted
Cleveland, Ohio, United States
GSK Investigational SiteRecruiting
Graz, Austria
GSK Investigational SiteRecruiting
Vienna, Austria
GSK Investigational SiteRecruiting
Kelowna, British Columbia, Canada
GSK Investigational SiteRecruiting
Toronto, Ontario, Canada
GSK Investigational SiteRecruiting
Montreal, Quebec, Canada
GSK Investigational SiteCompleted
Odense C, Denmark
GSK Investigational SiteCompleted
Nantes, France
GSK Investigational SiteCompleted
Nice, France
GSK Investigational SiteRecruiting
Haifa, Israel
GSK Investigational SiteRecruiting
Cremona, Italy
GSK Investigational SiteRecruiting
Madrid, Spain
GSK Investigational SiteRecruiting
Madrid, Spain
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study · TrialPath