Evaluation
gastrointestinal symptoms, tumor, neutropenia, febrile neutropenia, toxicity, thrombocytopenia, hypertension, Cancer
ADVERSE EVENT, TUMOR, NEUTROPENIA, FEBRILE NEUTROPENIA, ADVERSE EVENT, THROMBOCYTOPENIA, HYPERTENSION, CANCER
The primary endpoint was determination of the RP2D in the dose escalation cohort and frequency of febrile neutropenia in the expansion cohort. Adverse events (AEs) were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03. A DLT was defined as a cycle of one or 2 AEs that met one of the following criteria: grade 4 neutropenia lasting >7 days; grade ≥3 febrile neutropenia, grade 4 thrombocytopenia, or grade 3 thrombocytopenia requiring platelet transfusion; drug-related toxicity resulting in a >14-day delay in starting cycle 2 or 3; and grade ≥3 non-hematologic toxicity except for the following AEs: (1) grade ≥3 gastrointestinal symptoms that could be controlled by supportive care; (2) electrolyte and γGTP abnormalities; and (3) grade ≥3 hypertension that could be controlled. The population assessed for treatment safety included all patients who received one or more doses of the study drug.Antitumor responses were evaluated using RECIST version 1.1; each investigator performed tumor assessments at baseline and every 8 weeks and 12 weeks after week 32. Patients who had completed one or more treatment cycles and had undergone radiological/clinical progression assessments were evaluable for efficacy determination.