ABSTRACT
The primary objective of a conventional phase I oncology trial of a cytotoxic agent is to identify the maximum tolerated dose (MTD) for testing in subsequent studies. The major assumption is that both the probability of toxicity and the probability of therapeutic response are monotonically increasing with dose; therefore, by determining the MTD, one indirectly determines a dose with maximum potential for therapeutic effect. Many phase I trial designs for determining the MTD with a prespecified level of toxicity rate have been proposed in the literature [53].
