Dose-finding methods for molecularly targeted agents

2017 Fiscal Year Final Research Report

• Project/Area Number: 15K15948
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Statistical science
• Research Institution: The University of Tokyo (2017); Nagoya University (2015-2016)
• Principal Investigator: Hirakawa Akihiro 東京大学, 大学院医学系研究科(医学部), 特任准教授 (90609330)
• Project Period (FY): 2015-04-01 – 2018-03-31
• Keywords: ベイズ流デザイン / 用量探索 / がん臨床試験

Outline of Final Research Achievements

Molecularly targeted agents (MTAs) modulate specific aberrant pathways in cancer cells while sparing normal tissues, so that some MTAs do not necessarily need to be administered at their recommended dose to have maximal efficacy. Therefore, dose-finding methods that take into account the bivariate-correlating outcomes of both efficacy and toxicity are required for the clinical development of MTAs. In addition, the dose-efficacy model for MTAs is necessary to capture the specific relation between efficacy and the dose level. The efficacy may increase initially with the dose level but then reaches a plateau. We proposed a new dose-finding method using change-point model and also developed phase I/II design for combination of two agents.

Free Research Field

生物統計学