Patient monitoring
tumor, bleeding, Tumor, neutropenia, fatigue, toxicity, diarrhea, thrombocytopenia, fever, nausea,, Cancer
ADVERSE EVENT, TUMOR, BLEEDING, TUMOR, NEUTROPENIA, FEBRILE NEUTROPENIA, THROMBOCYTOPENIA, EVENTS, CANCER
Safety assessments were performed at least once every 3 weeks throughout the study treatment period and included physical examination, measurement of vital signs, clinical laboratory tests, 12-lead electrocardiography, and urinalysis. Cell counts, concomitant medication review, and collection of TEAEs were done weekly. TEAEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.Radiologic assessments of tumor response by computed tomography scan were conducted at baseline, every two cycles for the first six cyles, and at the end of every four cycles thereafter. Tumor response was measured using RECIST v1.1 [A DLT was defined as the occurrence of any of the following events, within the first cycle of treatment, that was considered to be at least possibly related to OBI-3424: grade 4 neutropenia lasting ≥7 days; febrile neutropenia; grade 4 thrombocytopenia; grade 3 thrombocytopenia with ≥grade 2 bleeding requiring platelet transfusions; any other grade 3 or 4 nonhematologic toxicity (except grade 3 fatigue, nausea, vomiting, or diarrhea that resolved to grade 1 or baseline level within 72 h; grade 3 fever [in the absence of neutropenia]; grade 3 asymptomatic laboratory abnormalities that resolved to grade 1 or baseline level within 72 h or were not clinically significant; and asymptomatic grade 3 elevations in liver enzymes that resolved to grade 1 or baseline level within 7 days); and persistent aspartate aminotransferase/alanine aminotransferase levels of >3× the upper limit of normal with concomitant bilirubin value of >2× the upper limit of normal that was not clearly related to something other than the study drug. The period for DLT observation was 21 days from the first dose of OBI-3424.