Practical Considerations for Adaptive Dose Finding in Phase I Oncology Studies Using Toxicity Probability Interval Approaches
Christine Gause, Merck *Linda Sun, Merck & Co. Keywords: dose finding, toxicity probability intervals In early phase oncology dose finding studies, the goal is to identify the maximum tolerated dose that has the potential to be efficacious for a single agent or a combination of two or more agents. We discuss the toxicity probability interval (TPI) approach (Ji et al. 2007) and the calibration-free modified TPI approach (Ji et al. 2010), which are adaptive designs that allow for the development of decision rules for toxicity intervals using a Bayesian framework. These types of designs are appealing to non-statisticians because they are easy to implement and dosing decisions can be pre-specified in the protocol. The statistical and practical considerations for the TPI/mTPI including choice of target toxicity rate, evaluation window, and MTD estimation will be presented along with examples illustrating the methods for both single agent and combination trials.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC