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
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.
Arms & interventions
- DrugNiraparib
Niraparib tablets or capsules will be given once a day via the oral route.
Outcome measures
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
Number of participants with use of concomitant medications
Number of participants using concomitant medications will be assessed.
Time frame: Up to 5 years
Eligibility criteria
Study locations (13)
GSK Investigational Site
Tucson, Arizona, 85710
GSK Investigational Site
Encinitas, California, 92024
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Whittier, California, 90603
GSK Investigational Site
Jacksonville, Florida, 32224
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Harvey, Illinois, 60426
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Grand Rapids, Michigan, 60637-1470
GSK Investigational Site
Morristown, New Jersey, 07962-1956
GSK Investigational Site
Lake Success, New York, 11042
GSK Investigational Site
Charlotte, North Carolina, 28204
GSK Investigational Site
Cleveland, Ohio, 44195