RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-04-16
Study Completion:2026-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04641247

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
  2. * Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.
  3. * 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.
  4. * Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.
  5. * 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.
  1. * Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.
  2. * 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.
  3. * 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).

Contacts and Locations

Study Contact

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

Principal Investigator

GSK Clinical Trials
STUDY_DIRECTOR
GlaxoSmithKline

Study Locations (Sites)

GSK Investigational Site
Tucson, Arizona, 85710
United States
GSK Investigational Site
Encinitas, California, 92024
United States
GSK Investigational Site
Los Angeles, California, 90048
United States
GSK Investigational Site
Whittier, California, 90603
United States
GSK Investigational Site
Jacksonville, Florida, 32224
United States
GSK Investigational Site
Atlanta, Georgia, 30342
United States
GSK Investigational Site
Harvey, Illinois, 60426
United States
GSK Investigational Site
Boston, Massachusetts, 02115
United States
GSK Investigational Site
Grand Rapids, Michigan, 60637-1470
United States
GSK Investigational Site
Morristown, New Jersey, 07962-1956
United States
GSK Investigational Site
Lake Success, New York, 11042
United States
GSK Investigational Site
Charlotte, North Carolina, 28204
United States
GSK Investigational Site
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

  • GSK Clinical Trials, STUDY_DIRECTOR, GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-16
Study Completion Date2026-11-13

Study Record Updates

Study Start Date2021-04-16
Study Completion Date2026-11-13

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Ovarian Neoplasms
  • Breast Neoplasms