A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
NCT ID: NCT04641247
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2021-04-16
2026-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Niraparib
Niraparib tablets or capsules will be given once a day via the oral route.
Interventions
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Niraparib
Niraparib tablets or capsules will be given once a day via the oral route.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Encinitas, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Whittier, California, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Harvey, Illinois, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Grand Rapids, Michigan, United States
GSK Investigational Site
Morristown, New Jersey, United States
GSK Investigational Site
Lake Success, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Graz, , Austria
GSK Investigational Site
Vienna, , Austria
GSK Investigational Site
Kelowna, British Columbia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Odense C, , Denmark
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Nice, , France
GSK Investigational Site
Haifa, , Israel
GSK Investigational Site
Cremona, , Italy
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-002667-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506618-29
Identifier Type: REGISTRY
Identifier Source: secondary_id
213409
Identifier Type: -
Identifier Source: org_study_id
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