Study Objectives and Assessments
toxicities, DLTs, Cancer
ADVERSE EVENT, SOLID TUMORS, CANCER
The primary objectives of this study were to evaluate the safety and tolerability of senaparib in patients with advanced solid tumors, and to determine the MTD and/or the RP2D for clinical trials in China. The PK profile of senaparib after single and multiple doses, and preliminary antitumor efficacy was also assessed.Safety was assessed by recording the incidence of dose-limiting toxicities (DLTs), and the incidence, nature, severity (graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [NCI CTCAE v4.03]The RP2D was determined based on all efficacy, safety, and PK data.