期刊
EXPERT REVIEW OF ANTICANCER THERAPY
卷 10, 期 3, 页码 427-438出版社
TAYLOR & FRANCIS LTD
DOI: 10.1586/ERA.09.178
关键词
biomarker; cytostatic agent; end point; enrichment; Phase II study; randomization; targeted therapy
类别
资金
- Singapore Millenium Foundation
The number of novel and molecularly targeted agents in the last decade that need screening for preliminary efficacy in Phase II trials has increased. Many of these agents have a cytostatic mode of action that is difficult to assess using traditional Phase II designs. These new agents require detailed evaluation to optimize their dosing, to evaluate their effects on their target and to define early markers that predict for a definitive benefit. This review focuses on the options for Phase II trial designs. The different end points, single versus multiarm and randomized designs, the use of biomarkers and Bayesian approaches are also reviewed. The final design chosen will depend on the characteristics and circumstances of each individual study.
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