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

NCT04641247 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 2134092020-002667-532023-506618-29
• Study Type: interventional
• Target: 30
• Locations: 8 countries
• Sites: 25

Brief 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.

Conditions

Ovarian Neoplasms; Breast Neoplasms

Keywords

Adverse events; Open-label extension; Parent study; Niraparib; Safety

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Number of participants with use of concomitant medications

  Number of participants using concomitant medications will be assessed.

  Up to 5 years

Study Arms (1)

Participants receiving niraparib

EXPERIMENTAL

Participants will receive niraparib once a day, continuously throughout each 90-day cycle until one of the following occurs: disease progression, unacceptable toxicity, initiation of new anticancer therapy that was not part of the parent study, withdrawal of consent, discontinuation at the discretion of the Investigator, noncompliance with protocol, death, or discontinuation for any other reason. The doses provided in this long-term treatment extension study will be those defined in the parent study for each enrolled participant. The starting dose of niraparib will be the same as the assigned dose and regimen that were given in the parent study.

Drug: Niraparib

Interventions

Niraparib DRUG

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

Participants receiving niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (25)

GSK Investigational Site

Tucson, Arizona, 85710, United States

COMPLETED

GSK Investigational Site

Encinitas, California, 92024, United States

RECRUITING

GSK Investigational Site

Los Angeles, California, 90048, United States

RECRUITING

GSK Investigational Site

Whittier, California, 90603, United States

COMPLETED

GSK Investigational Site

Jacksonville, Florida, 32224, United States

COMPLETED

GSK Investigational Site

Atlanta, Georgia, 30342, United States

RECRUITING

GSK Investigational Site

Harvey, Illinois, 60426, United States

RECRUITING

GSK Investigational Site

Boston, Massachusetts, 02115, United States

RECRUITING

GSK Investigational Site

Grand Rapids, Michigan, 60637-1470, United States

RECRUITING

GSK Investigational Site

Morristown, New Jersey, 07962-1956, United States

RECRUITING

GSK Investigational Site

Lake Success, New York, 11042, United States

RECRUITING

GSK Investigational Site

Charlotte, North Carolina, 28204, United States

RECRUITING

GSK Investigational Site

Cleveland, Ohio, 44195, United States

COMPLETED

GSK Investigational Site

Graz, A-8036, Austria

RECRUITING

GSK Investigational Site

Vienna, 1090, Austria

RECRUITING

GSK Investigational Site

Kelowna, British Columbia, V5Z 4E6, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

GSK Investigational Site

Odense C, 5000, Denmark

COMPLETED

GSK Investigational Site

Nantes, 44202, France

RECRUITING

GSK Investigational Site

Nice, 06189, France

COMPLETED

GSK Investigational Site

Haifa, 3109601, Israel

RECRUITING

GSK Investigational Site

Cremona, 26100, Italy

RECRUITING

GSK Investigational Site

Madrid, 28040, Spain

RECRUITING

GSK Investigational Site

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This will be an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive niraparib once a day, continuously throughout each 90-day cycle.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: April 16, 2021
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); AU (2); FR (2); CA (3); IL (1); US (13); IT (1); ES (2)