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

Abstract Details

Activity Number: 514
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #309097
Title: Dose-Escalation Approaches for Two Agents in Early-Phase Oncology Studies
Author(s): Yevgen Tymofyeyev and Christine K. Gause*+ and Keaven M. Anderson
Companies: Merck & Co., Inc. and Merck Research Laboratories and Merck Research Laboratories
Address: UG-1CD38 , North Wales, PA, 19454,
Keywords: dose escalation ; partial ordering ; maximum tolerated dose
Abstract:

In many early phase oncology dose finding studies, the goal is to identify the maximum tolerated dose (MTD) for a single agent or a combination of two or more agents. In single agent dose finding studies, the escalation path is straightforward, and statistical methods developed for these designs rely on the assumption of increasing toxicity with increasing dose. One challenge in dose finding with two agents is that an ordered path of dose escalation may be difficult to define. We propose a strategy to identify MTD in the two-agent setting that utilizes the partial ordering of treatment combinations. The algorithm potentially allows complete sequential 2D exploration of the combination plane without dose 'jumping'. A simulation study is conducted to compare the proposed algorithm with other dose-finding approaches for two agents.


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