• J Biopharm Stat · Jan 2015

    Seamless Phase I/II Adaptive Design for Oncology Trials of Molecularly Targeted Agents.

    • Nolan A Wages and Christopher Tait.
    • a Division of Translational Research & Applied Statistics, Department of Public Health Sciences , University of Virginia , Charlottesville , Virginia , USA.
    • J Biopharm Stat. 2015 Jan 1; 25 (5): 903-20.

    AbstractIn dose-finding trials of chemotherapeutic agents, the goal of identifying the maximum tolerated dose is usually determined by considering information on toxicity only, with the assumption that the highest safe dose also provides the most promising outlook for efficacy. Trials of molecularly targeted agents challenge accepted dose-finding methods because minimal toxicity may arise over all doses under consideration and higher doses may not result in greater response. In this article, we propose a new early-phase method for trials investigating targeted agents. We provide simulation results illustrating the operating characteristics of our design.

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