Endpoints
Tumors, Cancer
TUMORS, ADVERSE EVENT, SECONDARY, CANCER
The primary endpoints of the study were the safety and tolerability of trotabresib, as well as the MTD and/or RP2D of trotabresib. Safety was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03Secondary objectives were the preliminary efficacy of trotabresib in terms of clinical benefit rate (CR + PR + SD of ≥4 months’ duration), ORR (CR + PR), duration of response or SD, PFS, OS, and the PK of trotabresib. In addition, part C assessed the effects of food on the PK and the safety of trotabresib as a secondary objective. The pharmacodynamics of trotabresib were assessed as an exploratory objective.Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1