Overview of Trial Design Assessing Maintenance Niraparib in Treatment of Uterine Serous Carcinoma

Pharmacy Times interviewed Marina Frimer, MD, FACOG, FACS, gynecologic oncologist at the Northwell Health Cancer Institute and associate professor at Zucker School of Medicine in Hofstra/Northwell, on her presentation at the Society of Gynecologic Oncology 2022 annual meeting on the phase 2 trial of maintenance niraparib in patients with stage 3, stage 4, or platinum-sensitive recurrent uterine serous carcinoma.

During this interview, Frimer discussed the design of the phase 2 trial assessing niraparib in patients with stage III, stage IV, or platinum-sensitive recurrent uterine serous carcinoma.

Marina Frimer: So, this is a phase 2 prospective, nonrandomized, cohort study, and the trial will employ a Simon stage minimax design to test the null hypothesis that the 1-year response rate is less than 20%, which would not be clinically meaningful, versus the alternative hypothesis that the 1-year response rate is greater than 40%.