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Abstract Details
Activity Number:
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619
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2012 : 8:30 AM to 10:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305869 |
Title:
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Biological Optimum Dose-Finding Trials for Cancer Targeted Agents
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Author(s):
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Hao Liu*+
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Companies:
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Baylor College of Medicine
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Address:
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Division of Biostatistics, Houston, TX, 77030, United States
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Keywords:
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Early phase trial ;
Targeted therapy ;
Bayesian adaptive design ;
Cancer studies
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Abstract:
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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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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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