期刊
STATISTICS IN MEDICINE
卷 24, 期 14, 页码 2171-2181出版社
WILEY
DOI: 10.1002/sim.2102
关键词
phase I; toxicity; clinical trial
Traditional phase I dose-finding studies for chemotoxic agents base dose escalation on toxicity, with escalation continuing until unacceptable toxicity is observed. Recent development of molecularly targeted agents that have little or no toxicity in the therapeutic dose range has raised questions over the best study designs for phase I studies. Two types of designs are proposed and evaluated in this paper. In these designs, escalation is based on a binary response that indicates whether or not the agent has had the desired effect on the molecular target. One design is developed to ensure that if the true target response rate is low there will be a high probability of escalating and if the true target response rate is high there will be a low probability of escalating. The other design is developed to continue to escalate as long as the true response rate is increasing and to stop escalating when the response rate plateaus or decreases. A limited simulation study is performed and the designs are compared with respect to the dose level at the end of escalation and the number of patients treated on study. Published in 2005 by John Wiley & Sons, Ltd.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据