Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer.

1/11 https://ejgo.org ABSTRACT Objective: The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting. The median (min-max) body weight of patients was 53.9 (40.8- 79.1) kg and approximately 60% of patients weighed less than 58 kg, with all but one patient weighing less than 77 kg. One serious TEAE was recorded in 1 patient who experienced grade 4 thrombocytopenia on day 15 and niraparib was interrupted although the patient resumed treatment following resolution. [Extracted from the article]