A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04641247
• Other study ID #: 213409
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 16, 2021
• Est. completion date: November 13, 2025

Study information

• Verified date: July 2022
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: November 13, 2025
• Est. primary completion date: November 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.

• Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.

• Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective.

• Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.

• Participants 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.

Exclusion Criteria:

• Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.

• Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.

• Participant 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. Participant 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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms
• Ovarian Neoplasms

Intervention

Drug:
• Niraparib
Niraparib tablets or capsules will be given once a day via the oral route.

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Graz
Austria	GSK Investigational Site	Wien
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Denmark	GSK Investigational Site	Odense
France	GSK Investigational Site	Nantes cedex
France	GSK Investigational Site	Nice Cedex 2
Israel	GSK Investigational Site	Haifa
Italy	GSK Investigational Site	Cremona	Lombardia
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Marid
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Harvey	Illinois
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lake Success	New York
United States	GSK Investigational Site	Morristown	New Jersey
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	West Hollywood	California
United States	GSK Investigational Site	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)	AEs, SAEs and AESI will be collected.	Up to 5 years
Primary	Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status	The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Number of participants with clinically significant changes in ECOG performance status will be summarized.	Up to 5 years
Primary	Number of participants with clinically significant changes in hematology and clinical chemistry parameters	Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.	Up to 5 years
Primary	Number of participants with clinically significant changes in vital signs	Number of participants with clinically significant changes in vital signs will be assessed.	Up to 5 years
Primary	Number of participants with clinically significant changes in physical examination	Number of participants with clinically significant changes in physical examination will be assessed.	Up to 5 years
Primary	Number of participants with use of concomitant medications	Number of participants using concomitant medications will be assessed.	Up to 5 years