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Activity Number:
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211
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305318 |
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Title:
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EWOC 3.0: Interactive Software for Dose Escalation in Cancer Phase I Clinical Trials
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Author(s):
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Zhiheng Xu*+ and Mourad Tighiouart and Andre Rogatko and Lin Pan
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Companies:
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Emory University and Emory University and Cedars-Sinai Medical Center and Emory University
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Address:
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1365B Clifton Road, Atlanta, GA, 30322,
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Keywords:
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Escalation with overdose control (EWOC) ; Maximum tolerated dose (MTD) ; Dose limiting toxicity (DLT)
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Abstract:
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EWOC is a method for selecting dose levels in cancer phase I clinical trials while controlling the probability of exceeding MTD. Previous versions of EWOC software have been used to design cancer phase I studies by several cancer centers and pharmaceutical companies. EWOC 3.0 contains a new simulation module and trial design using cohorts of size 2 or 3. In the simulation module, researchers can enter a discrete set of doses along with a priori probabilities of dose limiting toxicities at these doses. The software returns results from simulated trials showing the percent of patients allocated to each dose level, the percent of patients experiencing DLT at each dose level, and the percent of time doses were skipped during the trial. The simulation module will help statisticians and clinicians assess the rate of convergence of the sequence of doses to the MTD and the safety of the trial.
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