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Marcio A. Diniz

Cedars-Sinai Medical Center



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José L. Jimenez

Politecnico di Torino



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Mourad Tighiouart

Cedars-Sinai Medical Center



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243 – Contributed Poster Presentations: Biopharmaceutical Section

Escalation with Overdose Control for Drug Combination Using Time to Toxicity Data in Cancer Phase I Trials

Sponsor: Biopharmaceutical Section
Keywords:

Marcio A. Diniz

Cedars-Sinai Medical Center

José L. Jimenez

Politecnico di Torino

Mourad Tighiouart

Cedars-Sinai Medical Center

Bayesian adaptive methods for phase I trials such as the continual reassessment method (CRM) and escalation with overdose control (EWOC) do not take into account the time for a patient exhibits dose limiting toxicity (DLT), since the toxicity outcome is treated as a binary variable. This characteristic is proven to increase the study duration and makes it almost non-feasible in practice. Despite there are several methodologies to overcome this limitation in single agent trials, there only a few approaches specifically designed for drug combinations that model the time to toxicity. In this paper, we propose a Bayesian adaptive EWOC design that incorporates both the status of DLT and the time to toxicity using a cure rate model in clinical trials with drug combinations.

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