|
Activity Number:
|
493
|
|
Type:
|
Invited
|
|
Date/Time:
|
Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #303163 |
|
Title:
|
Ups and Downs of Implementing BLR-EWOC Guided Dose Escalation at Novartis Oncology
|
|
Author(s):
|
Jyotirmoy Dey*+
|
|
Companies:
|
Novartis Pharmaceuticals
|
|
Address:
|
180 Park Avenue, Florham Park, NJ, 07932,
|
|
Keywords:
|
Dose-escalation ; Bayesian Logistic Regression ; EWOC ; Maximum Tolerated Dose ; 3+3 ; Cancer
|
|
Abstract:
|
Identification of the maximum tolerated dose (MTD) in Phase I cancer trials can be nicely formulated as a model-based estimation problem. Excellent Bayesian adaptive methods based on various dose-toxicity models are now available that clearly out-perform the traditional "3+3" algorithm. In this talk various implementations of Bayesian logistic regression (BLR) guided by the Escalation with Overdose Control (EWOC) criteria for dose escalation studies at Novartis is discussed. Pragmatic aspects of the BLR-EWOC including evaluation of new therapies as single-agent and/or in combination, multiple dosing schedules, flexible cohort sizes and incorporation of relevant covariates are presented. The multidisciplinary approach of determining the dose for the next cohort through clinical synthesis of all available information is particularly highlighted.
|
