Endpoints
PD, death, Cancer
ADVERSE EVENT, CANCER
The primary endpoint was independent review committee (IRC)-assessed ORR, defined as the proportion of patients with complete response (CR) or partial response (PR) as per RECIST 1.1 with a similar observation at least 28 days later. Secondary endpoints included CBR, OS, PFS, and safety evaluation. OS was determined to be the time to death due to any cause occurring after the first dose and PFS was defined as the time from starting treatment to PD as per RECIST 1.1 or death. Safety was assessed based on symptoms and clinical laboratory parameters at a central laboratory. AE severity was graded by the investigators according to Common Terminology Criteria for Adverse Events (CTCAE; Version 4.03). Treatment emergent AEs (TEAEs) were defined as AEs occurring from the first dose to 30 days after receiving the last dose of the study drug.Other endpoints included HRQoL assessment by the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index 19 Item Version (FKSI-19). An exploratory examination of the protein levels of HGF, MET, GAS6, and AXL was performed.