Dose-finding design based on level set estimation in phase I cancer clinical trials

Dose-finding design based on level set estimation in phase I cancer clinical trials Keiichiro Seno 1 a, Kota Matsui 2b, Shogo Iwazaki 3, Yu Inatsu 4, Shion Takeno 5, 6 and Shigeyuki Matsui 2, 7 1 Department of Biostatistics, Nagoya University 2 Department of Biostatistics, Kyoto University 3 MI-6 Ltd. 4 Department of Computer Science, Nagoya Institute of Technology 5 Department of Mechanical Systems Engineering, Nagoya University 6 Center for Advanced Intelligence Project, RIKEN 7 Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics Abstract 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 ...