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Abstract Details
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Activity Number:
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351
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Type:
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Contributed
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Date/Time:
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Tuesday, August 2, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #302177 |
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Title:
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A Range of Practical Issues in Pediatric Early Phase Trials: Dosing Approaches and Empirical vs. Model-Based Phase I Designs
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Author(s):
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Arzu Onar-Thomas*+
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Companies:
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St. Jude Children's Research Hospital
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Address:
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262 Danny Thomas Place, Memphis, TN, 38105,
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Keywords:
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Continual Reassessment Method ;
Phase I Trial ;
MTD
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Abstract:
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Pediatric Phase I trials can differ from their adult counterparts and pose unique challenges. One specific issue is with respect to dosing oral agents, which is often based on body surface area in pediatrics. With fixed pill sizes and without availability of pediatric formulations, using such agents in a Phase I setting requires special care for ensuring safety and for estimating the maximum tolerated dose. Various dose-finding designs are available for Phase I trials, some empirical and others model-based. Here we will present extensive simulation results that compare the performance of empirical designs, specifically the Rolling-6 and the Traditional Method, to each other and to the continuous reassessment method with respect to accuracy, sample size and toxicity. The advantages/disadvantages of using each design will be highlighted in the context of pediatric Phase I oncology trials.
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