Patient assessments and evaluation
toxicity
All patients who received at least one dose of LXI-15029 were included in the safety and toxicity evaluations. Safety evaluations were performed on days 1, 8, 15, and 22 in cycle 1 and once every month after that. The safety assessments included vital signs, laboratory tests, and an electrocardiogram. Safety data were evaluated separately. At the end of the study, all safety data were analyzed appropriately according to the statistical analysis plan. The AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA version 24.0). The AE severity was graded according to the NCI-CTCAE 4.03.The antitumor effects of LXI-15029 monotherapy was evaluated based on ORR, DCR, and PFS according to RECIST version 1.1 on week 4 and every 8 weeks thereafter, and the best overall response was confirmed at least 4 weeks after the initial response.