This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309013
Title: Implementation of EWOC (Escalation With Overdose Controls) Adaptive Dose-Finding Design in a Phase IIA Clinical Trial
Author(s): Catherine Bresee*+ and Amir Steinberg and Jeremy Rudnick and Andre Rogatko
Companies: Oschin Comprehensive Cancer Institute and Oschin Comprehensive Cancer Institute and Oschin Comprehensive Cancer Institute and Oschin Comprehensive Cancer Institute
Address: Cedars-Sinai Medical Center, Los Angeles, CA, 90048,
Keywords: Adaptive design ; Dose-finding ; Oncology ; Clinical Trial

In oncology, clinical treatment studies are often hampered by small patient populations in rare disease cases. To determine the maximum tolerated dose (MTD) with as few patients as possible, we used EWOC as an adaptive dose-finding design in a Phase IIA clinical trial of temozolomide for off-label use in the treatment of primary CNS lymphoma. Advantages of EWOC are (a) it is adaptive using all currently available data in determining subsequent dosing using Bayesian principles, (b) the predicted proportion of patients receiving an overdose is controlled, and (c) the sequence of doses approaches the MTD rapidly. Here we describe several dosing scenarios using EWOC with varying overdose control parameters.

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