Patient specific dosing in a cancer phase I clinical trial

被引:55
作者
Babb, JS [1 ]
Rogatko, A [1 ]
机构
[1] Fox Chase Canc Ctr, Dept Biostat, Philadelphia, PA 19111 USA
关键词
D O I
10.1002/sim.848
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Recent improvements in our understanding of drug metabolism have led to the development of anticancer therapies that accommodate patient differences in drug tolerance. Such methods adjust the dose level according to measurable patient characteristics in order to obtain a target drug exposure. This paper describes the utilization of a patient specific dosing scheme in the statistical design of a phase I clinical trial involving patients with advanced adenocarcinomas of gastrointestinal origin. During the trial, dose levels 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 continual adjustment of the model used to tailor the dose to each patient's individual needs. Copyright (C) 2001 John Wiley & Sons, Ltd.
引用
收藏
页码:2079 / 2090
页数:12
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