Patient specific dosing in a cancer phase I clinical trial

Recent improvements in our understanding of drug metabolism have led to the development of anticancer therapies that accommodate patient differences i n drug tolerance. Such methods adjust the dose level according to measurabl e patient characteristics in order to obtain a target drug exposure. This p aper describes the utilization of a patient specific dosing scheme in the s tatistical design of a phase I clinical trial involving patients with advan ced adenocarcinomas of gastrointestinal origin. During the trial, dose leve ls were adjusted according to each patient's pretreatment concentration of an antibody that was shown in preclinical testing to moderate the effect of the agent under investigation. The design of the trial permitted a continu al adjustment of the model used to tailor the dose to each patient's indivi dual needs. Copyright (C) 2001 John Wiley & Sons, Ltd.