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
Date de révision : 30/04/2026
Homme Femme
A partir de 18 ans
Date de début de recrutement : 09/10/2023
Critères :
Critères d'inclusion :
- 1. Subject is able to understand the study procedures and agrees to participate in the study by providing written informed consent. 2. Subject is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. 3. Subject is currently receiving treatment with niraparib (as monotherapy or in combination) in a GSK/TESARO-sponsored study that has fulfilled the requirements for the primary objective. 4. Subject is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements. 5. Subjects 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. -Male subjects must use a condom and must not donate sperm during study treatment with niraparib and for 90 days after receiving the last dose of Study Drug.
Critères d'exclusion :
- 1. Subject has been permanently discontinued from niraparib treatment in the parent study for any reason. 2. Subject currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Subjects meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. 3. Subject 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. Subject 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).
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".