Dose expansion cohorts in Phase I trials.

ABSTRACT: A rapidly increasing number of Phase I dose-finding studies, and in particular those based on the standard 3+3 design, are being prolonged with the inclusion of dose expansion cohorts (DEC) in order to better characterize the toxicity profiles of experimental agents and to study disease-specific cohorts. These trials consist of two phases: the usual dose escalation phase that aims to establish the maximum tolerated dose (MTD), and the dose expansion phase that accrues additional patients, often with different eligibility criteria, and where additional information is collected. Current protocols do not always specify whether and how the MTD will be updated in light of the new data accumulated from the DEC. In this paper, we propose methods that allow monitoring of safety in the DEC by re-ev

SUBMITTER: Iasonos A 

PROVIDER: S-EPMC4976787 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature