A Bayesian optimal interval design considering efficacy and toxicity in early phase basket trials
Tuesday, Aug 5: 8:55 AM - 9:15 AM
Topic-Contributed Paper Session
Music City Center
The primary goal of dose-finding trials for novel anti-cancer agents is to identify an optimal dose (OD) that balances efficacy and tolerability, unlike traditional cytotoxic agents where the maximum tolerated dose (MTD) is sought. Novel agents may exhibit non-monotonic dose–efficacy relationships, necessitating model-based and model-assisted designs to determine ODs. The FDA's Project Optimus aims to optimize cancer drug doses for efficacy, safety, and tolerability. Advances in biomarker development and precision medicine have shifted cancer treatment paradigms towards targeting specific molecular profiles, requiring new trial designs like early-phase basket trials. These trials assess new treatments across multiple cancer types or subtypes, identifying sensitive and insensitive baskets. We extend the BOIN-ET design to phase I/II basket trials, introducing the "BOIN-ETB" design, which is model-assisted and straightforward to implement. A simulation study explores the BOIN-ETB design's properties and compares its operating characteristics with other dose-finding approaches in oncology.
basket trial
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