Materials and Methods
Tumors, Cancer, adenocarcinoma of the colon
DISEASE PROGRESSION, ADVERSE EVENT, ADENOCARCINOMA OF THE COLON, ADVERSE EVENTS, DISEASE, TUMORS, SECONDARY, ONCOLOGY, CANCER
In this open-label, global, phase I trial, adult patients with histologically confirmed advanced adenocarcinoma of the colon or rectum that progressed during or after second-line treatment, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 were included. Patients must have had disease progression while receiving fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab, and cetuximab or panitumumab (for The primary endpoint was confirmed best overall response (BOR) according to RECIST 1.1, as assessed by an independent review committee (IRC). The key secondary endpoint was safety, with adverse events coded according to Medical Dictionary for Regulatory Activities terms version 21.0 and classified by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Exploratory endpoints included progression-free survival (PFS), overall survival (OS), and duration of response (