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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasms; Ovarian Neoplasms
• Intervention / Treatment: Drug: Niraparib

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • GSK Investigational Site
  • Wien, Austria, 1090
    • GSK Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • GSK Investigational Site
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • GSK Investigational Site
• Denmark
  • Odense, Denmark, 5000
    • GSK Investigational Site
• France
  • Nantes cedex, France, 44202
    • GSK Investigational Site
  • Nice Cedex 2, France, 06189
    • GSK Investigational Site
• Israel
  • Haifa, Israel, 3109601
    • GSK Investigational Site
• Italy
  • Lombardia
    • Cremona, Lombardia, Italy, 26100
      • GSK Investigational Site
• Spain
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Marid, Spain, 28040
    • GSK Investigational Site
• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • GSK Investigational Site
  • California
    • West Hollywood, California, United States, 90048
      • GSK Investigational Site
    • Whittier, California, United States, 90603
      • GSK Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32224
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
  • Illinois
    • Harvey, Illinois, United States, 60426
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • GSK Investigational Site
  • New Jersey
    • Morristown, New Jersey, United States, 07962-1956
      • GSK Investigational Site
  • New York
    • Lake Success, New York, United States, 11042
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Participants receiving niraparib; 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; Niraparib tablets or capsules will be given once a day via the oral route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2021
• Primary Completion (ANTICIPATED): November 13, 2025
• Study Completion (ANTICIPATED): November 13, 2025

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (ACTUAL): November 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Niraparib; Adverse events; Open-label extension; Parent study
• Additional Relevant MeSH Terms: Skin Diseases; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Niraparib
• Other Study ID Numbers: 213409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No