The primary objective of a Phase I oncology trial is to determine the maximum tolerated dose (MTD) of a new experimental regimen. The general assumption is that as dose is increased, greater efficacy will be achieved; hence, the search for the highest dose level compatible with an acceptable toxicity profile. This assumption is certainly reasonable, particularly for cytotoxic drugs, although it need not always be the case. For example, the maximum beneficial effect of immunomodulating agents may occur at intermediate dosages, or the degree of efficacy may plateau so that little is gained by increasing the dose beyond a certain level. These situations create further design and analytical challenges that are probably best addressed in a randomized comparative setting. For the remainder of this section, we assume that the primary aim of a Phase I trial is to determine the MTD, under the assumption that the highest dose will produce the greatest beneficial effects. Secondary objectives may be to conduct pharmacokinetic studies in individual patients or detect evidence of antitumor activity. More recently, a better knowledge of drug metabolic pathways and pharmacogenomics is beginning to be incorporated into some trial designs, with the goal being to evaluate the relationship between toxicity and genotype.5

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