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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Niraparib tablets or capsules will be given once a day via the oral route.
GSK Investigational Site
Tucson, Arizona, United States
COMPLETEDGSK Investigational Site
Encinitas, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Whittier, California, United States
COMPLETEDGSK Investigational Site
Jacksonville, Florida, United States
COMPLETEDGSK Investigational Site
Atlanta, Georgia, United States
RECRUITINGGSK Investigational Site
Harvey, Illinois, United States
RECRUITINGGSK Investigational Site
Boston, Massachusetts, United States
RECRUITINGGSK Investigational Site
Grand Rapids, Michigan, United States
RECRUITINGGSK Investigational Site
Morristown, New Jersey, United States
RECRUITING...and 15 more locations
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
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