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.

Key Words:

• Combination
• Dose-finding studies
• Multiple dosing
• Phase I trials

Additional information

Funding

This work was supported by the Japan Society for the Promotion of Science KAKENHI, Grant Number 25730015 (Grant-in-Aid for Young Scientists B).