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Full-Text Articles in Medical Biomathematics and Biometrics
Dose Expansion Cohorts In Phase I Trials, Alexia Iasonos, John O'Quigley
Dose Expansion Cohorts In Phase I Trials, Alexia Iasonos, John O'Quigley
Memorial Sloan-Kettering Cancer Center, Dept. of Epidemiology & Biostatistics Working Paper Series
A rapidly increasing number of Phase I dose-finding studies, and in particular those based on the standard 3+3 design, frequently prolong the study and include dose expansion cohorts (DEC) with the goal 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 being collected. Current protocols typically do not specify whether the MTD will be updated …
Dose Expansion Cohorts In Phase I Trials, Alexia Iasonos, John O'Quigley
Dose Expansion Cohorts In Phase I Trials, Alexia Iasonos, John O'Quigley
Alexia Iasonos
A rapidly increasing number of Phase I dose-finding studies, and in particular those based on the standard 3+3 design, frequently prolong the study and include dose expansion cohorts (DEC) with the goal 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 being collected. Current protocols typically do not specify whether the MTD will be updated …