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Activity Number:
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26
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Type:
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Contributed
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Date/Time:
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Sunday, August 2, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304869 |
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Title:
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Bayesian Phase I/II Drug-Combination Trial Design in Oncology
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Author(s):
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Ying Yuan*+ and Guosheng Yin
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Companies:
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The University of Texas M.D. Anderson Cancer Center and The University of Texas M.D. Anderson Cancer Center
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Address:
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1400 Pressler St, Unit 1411, Houston, TX, 77030,
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Keywords:
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Adaptive design ; Bayesian inference ; Adaptive randomization
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Abstract:
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We propose a new integrated phase I/II trial design to identify the most efficacious dose combination that also satisfies certain safety requirements for drug-combination trials. We first take a Bayesian copula-type model for dose finding in phase I. After identifying a set of admissible doses, we immediately move the entire set forward in parallel to phase II. We propose a novel adaptive randomization scheme to favor assigning patients to more efficacious dose-combination arms. Our adaptive randomization scheme takes into account both the rate and variability of efficacy. By using an adaptive reference to compare the relative efficacy among treatment arms, our method achieves a high resolution to distinguish different arms. We illustrate the proposed method using a phase I/II melanoma clinical trial.
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