Safety
Cancer, treatment-emergent adverse, Treatment-emergent adverse, pain
CANCER, ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, INDURATION, EVENTS, EVENTS, INDURATION
Safety assessments involved analysis of all 26 patients. Twenty-three patients (88%) completed the study, and 3 patients discontinued treatment because of adverse events (2 patients) or compliance-related issues (1 patient). Among all 26 patients, 9 patients initially received injections at dose levels of 2, 3, and 4 mg/kg (3 patients for each dose level). Induration or pain at the injection sites was observed during the study, but the adverse events were low grade (grade 1 and 2) and well tolerated. The cohorts receiving 3 and 4 mg/kg were then expanded to include 9 patients in each cohort. Similar injection-related events were reported and were again well tolerated by the patients. However, treatment was discontinued in one patient because of poor compliance After completion of safety assessments, the doses were then increased to 5.5 mg/kg and 7 mg/kg. Two DLT events were observed in the 7 mg/kg cohort, in which grade 3 muscle-related injection induration was noted. The events resolved naturally without intervention after discontinuation of the test drug. Overall, the MTD was determined to be 5.5 mg/kg once daily.Adverse events and treatment-emergent adverse events are summarized in Treatment-emergent adverse events**Calculations were based on 26 patients who received at least one dose of chlorogenic acid. Events were considered treatment-related, on the basis of assessment by the site investigators. The grade of adverse events was defined according to The National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.0).