JSM 2004 - Toronto

Abstract #301858

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Activity Number: 264
Type: Topic Contributed
Date/Time: Tuesday, August 10, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #301858
Title: Clinical Trial Designs for Dose-seeking, Non-MTD Trials with Biomarker Endpoints
Author(s): Sumithra J. Mandrekar*+ and Wei Zhang and Susan M. Geyer and Vera Suman and Karla Ballman and Antje Hoering and Daniel Sargent
Companies: Mayo Clinic and University of Iowa and Mayo Clinic and Mayo Clinic and Mayo Clinic and Mayo Clinic and Mayo Clinic
Address: 200 First St. SW, Rochester, MN, 55905,
Keywords: biomarkers ; clinical trials ; designs ; simulations
Abstract:

Historically, designs for dose-seeking trials have been geared towards finding the maximum tolerated dose (MTD), with safety as the primary outcome. With target-based anticancer agents whose dose response curves are unknown and whose dose/toxicity relationship are expected to be minimal, alternative designs to identify the biologically optimal dose have become necessary. The type of dose response relationship is also usually unknown for these agents. Using simulation, we compare various designs (e.g., cohorts of k individuals, randomization among d predetermined dose levels, continuous reassessment methods, accelerated titration) for determining the optimal dose of a targeted therapy under different types of dose-response relationships (e.g., linear, quadratic, increasing with a plateau). We assume the therapy is nontoxic for the dose range of interest and that the endpoint can be assessed in a relatively easy, reliable, and timely manner. The designs are compared with respect to expected sample size, the number of patients treated at a suboptimal dose, distance the selected dose is from the optimal dose, expected trial duration, plus several other pragmatic considerations.

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Revised March 2004