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Bibliographic Details
Main Authors: Seno, Keiichiro, Matsui, Kota, Iwazaki, Shogo, Inatsu, Yu, Takeno, Shion, Matsui, Shigeyuki
Format: Preprint
Published: 2025
Subjects:
Online Access:https://arxiv.org/abs/2504.09157
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Table of Contents:
  • The primary objective of phase I cancer clinical trials is to evaluate the safety of a new experimental treatment and to find the maximum tolerated dose (MTD). We show that the MTD estimation problem can be regarded as a level set estimation (LSE) problem whose objective is to determine the regions where an unknown function value is above or below a given threshold. Then, we propose a novel dose-finding design in the framework of LSE. The proposed design determines the next dose on the basis of an acquisition function incorporating uncertainty in the posterior distribution of the dose-toxicity curve as well as overdose control. Simulation experiments show that the proposed LSE design achieves a higher accuracy in estimating the MTD and involves a lower risk of overdosing allocation compared to existing designs, thereby indicating that it provides an effective methodology for phase I cancer clinical trial design.