Study design and participants
Cancer, toxicity, NCI10066
ONCOLOGY, DISEASE, ADENOCARCINOMA, CANCER
NCI10066 was a single-arm open-label Phase 1/2 clinical trial open through the National Cancer Institute (NCI) ETCTN. Eligible patients had stage IV, histopathologically confirmed gastric or GEJ adenocarcinoma that had progressed after at least one standard therapy in the metastatic setting. The study consisted of a dose escalation portion followed by dose expansion. The dose escalation proceeded with a standard 3 + 3 design with a dose-limiting toxicity evaluation period for 28 days from treatment initiation. In dose expansion, enrolment proceeded at the RP2D. Eligible patients were 18 years of age or older, had measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST, version 1.1), had an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1, and had adequate organ function (as assessed by renal, hepatic, and haematologic parameters). Patients were excluded if they had previously received ramucirumab. The NCI Cancer Therapy Evaluation Program and the NCI Central Institutional Review Board approved the protocol and all patients provided written informed consent. The full study protocol is available in the supplementary data. The study was conducted in accordance with the Declaration of Helsinki and followed the Consolidated Standards of Reporting Trials. Trial registration: ClinicalTrials.gov identifier: (NCT03008278).