Abstract #300491

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JSM 2003 Abstract #300491
Activity Number: 176
Type: Contributed
Date/Time: Monday, August 4, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300491
Title: Adaptive Designs for Dose Escalation Studies Using Graded Toxicities
Author(s): Vladimir Dragalin*+
Companies: Smith Kline Beecham
Address: 1250 S Collegeville Rd., Collegeville, PA, 19426-0989,
Keywords: adaptive designs ; dose escalation ; ordered multinomial model ; maximum tolerated dose ; graded toxicities ; optimal design of experiments
Abstract:

Although most designs for dose-finding consider dose-limiting toxicities as a binary outcome, many Phase I oncology trials record information on the degree of toxicity, from 0, no adverse events, to 4, very serious or life threatening toxicity. In order to use this information, we consider ordered multinomial models linking the cumulative toxicity probabilities with the linear regression structure. The theory of optimal experimental design is applied to provide efficient adaptive procedures to estimate a level of dose whose probability of dose-limiting toxicity is closest to a given percentile of the dose-toxicity curve.

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Revised March 2003