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

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 (3000-04-003)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002667-53-AT

Enrollment

Registered

2021-04-29

Start date

2021-08-23

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced ovarian, breast, or prostate cancer MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Orga

Interventions

Trade Name: Zejula 100mg hard capsules Product Name: NIRAPARIB Product Code: GSK 3985771, MK-4827 Pharmaceutical Form: Capsule INN or Proposed INN: Niraparib CAS Number: 1038915-60-4 Current Sponsor c

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Primary

Measure	Time frame
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: No efficacy endpoints will be evaluated in this study. Safety: Safety will be evaluated based on the incidence of treatment emergent AEs (TEAEs; including treatment discontinuation and dose modifications due to AEs), SAEs, AESIs, changes in ECOG performance status, changes in clinical laboratory assessments (hematology and chemistry), vital sign measurements, observations during physical examination, and use of concomitant medications (excluding any study drugs used in the parent study). All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedRA) coding system outlined in the statistical analysis plan.;Timepoint(s) of evaluation of this end point: as defined in endpoints	—

Measure

Time frame

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: No efficacy endpoints will be evaluated in this study. Safety: Safety will be evaluated based on the incidence of treatment emergent AEs (TEAEs; including treatment discontinuation and dose modifications due to AEs), SAEs, AESIs, changes in ECOG performance status, changes in clinical laboratory assessments (hematology and chemistry), vital sign measurements, observations during physical examination, and use of concomitant medications (excluding any study drugs used in the parent study). All AEs will be coded using the Medical Dictionary for Regulatory Activities (MedRA) coding system outlined in the statistical analysis plan.;Timepoint(s) of evaluation of this end point: as defined in endpoints

—

Countries

Austria, Canada, Denmark, France, Israel, Italy, Spain, United States

Contacts

Public ContactGSK Clinical Support Help Desk

GlaxoSmithKline Research & Development Limited

GSKClinicalSupportHD@gsk.com448007839733

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026