A Dose-Finding Method Based on Multiple Dosing in Two-Agent Combination Phase I Trials.

ABSTRACT

Here, we developed a new dose-finding method that partitions a cohort of patients based on the number of dose combinations within a prespecified acceptable toxicity range in two-agent combination Phase I trials. In the proposed method, patients in the same cohort are partitioned according to several dose combinations, although most of the existing methods allocate patients in the same cohort according to a single-dose combination. We compared the operating characteristics of the proposed and existing methods through simulation studies.