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Activity Number:
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322
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Type:
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Contributed
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Date/Time:
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Tuesday, August 4, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biometrics Section
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| Abstract - #305148 |
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Title:
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Estimation of Safe and Effective Dose in Phase I Clinical Trials in Oncology
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Author(s):
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Motomi Mori*+ and Yiyi Chen and Joshi Alumkal
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Companies:
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Oregon Health & Science University and Oregon Health & Science University and Oregon Health & Science University
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Address:
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3181 SW Sam Jackson Park Road, Portland, OR, 97239-3098,
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Keywords:
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accelerated titration design ; adaptive design ; cancer ; dose-finding
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Abstract:
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A traditional phase I oncology trial is designed under the assumption that a higher dose is more efficacious and attempts to estimate the Maximum Tolerated Dose (MTD). However, such a paradigm does not work well for newer generation of drugs. In this presentation, we propose a modification of the accelerated titration design, originally proposed by Simon R (JNCI 1997), to accommodate both toxicity and biological activity. The proposed design has an accelerated phase and the standard 3+3 phase, but the escalation rule based on observed toxicity and biological activity. It has appropriate operating characteristics under various dose response functions. We will illustrate an application of this design to a phase I trial of Sulforaphane in men with rising PSA after the primary therapy for prostate cancer.
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