EXTENSION STUDY FOR PATIENTS WHO HAVE COMPLETED A PRIOR GLAXOSMITHKLINE/TESARO-SPONSORED NIRAPARIB STUDY AND ARE JUDGED BY THE INVESTIGATOR TO BENEFIT FROM CONTINUED TREATMENT WITH NIRAPARIB

Phase 1

Recruiting

Conditions: Advanced ovarian, breast, or prostate cancer
MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864
MedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864
MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-506618-29-00

Lead Sponsor: Glaxosmithkline Research & Development Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

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.

Exclusion Criteria

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).