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Abstract:
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Pediatric Phase I trials do differ from their adult counterparts and pose unique challenges. One specific issue concerns dosing oral agents, which is often based on body surface area (BSA) 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 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 in pediatric settings taking into account BSA based dosing. The advantages/disadvantages of using each design are highlighted in the context of pediatric Phase I oncology trials.
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