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Abstract Details

Activity Number: 619
Type: Contributed
Date/Time: Thursday, August 2, 2012 : 8:30 AM to 10:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305869
Title: Biological Optimum Dose-Finding Trials for Cancer Targeted Agents
Author(s): Hao Liu*+
Companies: Baylor College of Medicine
Address: Division of Biostatistics, Houston, TX, 77030, United States
Keywords: Early phase trial ; Targeted therapy ; Bayesian adaptive design ; Cancer studies

Biological targeted agents can generate optimal treatment effect at a level well below the maximum tolerated dose. Toxicity-guided dose selection designs thus may not work for the purpose of finding the biologically optimal dose level. In this article, we propose a Bayesian adaptive design for dose-finding trials guided by biological responses that directly measure the targeted effect of the study agent. A subject will receive the treatment at the dose level that has the best chance for improving biological response, provided that the dose level has limited toxicity. In addition, a Bayesian rule is incorporated to stop a trial early based on the predictive probability of adverse events. Simulation studies show that the method performed reasonable well. We illustrate the method using an example of a dose-finding trial in advanced renal cell carcinoma.

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