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

Official Title

An Open-Label, Multicentre, 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.

Trial Description

Primary Outcome:

• Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
• Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
• Number of participants with clinically significant changes in hematology and clinical chemistry parameters
• Number of participants with clinically significant changes in vital signs
• Number of participants with clinically significant changes in physical examination
• Number of participants with use of concomitant medications

View this trial on ClinicalTrials.gov