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

Lead Sponsor: GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 59

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.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of niraparib;Secondary Objective: No secondary objectives will be evaluated in this study.;Primary end point(s): Efficacy:<br>No efficacy endpoints will be evaluated in this study.<br>Safety:<br>Safety will be evaluated based on the incidence of treatment emergent<br>AEs (TEAEs; including treatment discontinuation and dose modifications<br>due to AEs), SAEs, AESIs, changes in ECOG performance status, changes<br>in clinical laboratory assessments (hematology and chemistry), vital sign<br>measurements, observations during physical examination, and use of<br>concomitant medications (excluding any study drugs used in the parent<br>study). All AEs will be coded using the Medical Dictionary for Regulatory<br>Activities coding system outlined in the statistical analysis plan.;Timepoint(s) of evaluation of this end point: as defined in endpoints

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

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