Clinical Trial Designs for Cytostatic Agents: Are New Approaches Needed?
作者： Edward L. Korn , Susan G. Arbuck , James M. Pluda , Richard Simon , Richard S. Kaplan
DOI: 10.1200/JCO.2001.19.1.265
关键词:
摘要: ABSTRACT: Preclinical data suggest that some new anticancer agents directed at novel targets demonstrate tumor growth inhibition but not shrinkage. Such cytostatic may offer clinical benefits for patients in the absence of In addition, lower doses these be just as effective higher doses, implying toxicity an ideal end point dose finding. Because factors, sequence and design traditional phase I, II, III trials used cytotoxic (which typically shrink tumors a dose-dependent manner) appropriate agents. This article discusses options modifying trial designs to accommodate Examples are given where have been tried or currently being tried. Recommendations choosing among depend on what is known preclinically about (eg, does one validated reproducible biologic can t...
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