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

• Conditions: advanced ovarian, breast, or prostate cancer; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002667-53-AT
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-29
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified