Niraparib: Niraparib tablets or capsules will be given once a day via the oral route.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy 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).
Primary outcome measure(s)
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) — Up to 5 years AEs, SAEs and AESI will be collected.
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status — Up to 5 years 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.
Number of participants with clinically significant changes in hematology and clinical chemistry parameters — Up to 5 years Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.
Number of participants with clinically significant changes in vital signs — Up to 5 years Number of participants with clinically significant changes in vital signs will be assessed.
Number of participants with clinically significant changes in physical examination — Up to 5 years Number of participants with clinically significant changes in physical examination will be assessed.
Number of participants with use of concomitant medications — Up to 5 years Number of participants using concomitant medications will be assessed.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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