Objectives and Clinical Issues

Phase II clinical trials are conducted to determine whether a new agent or regimen has sufficient antitumor activity, usually measured in terms of reduction in tumor size, to warrant further study. Secondary objectives are to collect additional safety and toxicity data, and correlative studies to evaluate the effects of treatment on specific biomarkers or other intermediate endpoints may be included. It is assumed that the drug dose and administration schedule will have been determined from prior Phase I trials.

Unlike Phase I studies, Phase II trials should be performed in a single, well-defined tumor type and patient population. The extent of disease, patient performance status, and the amount of prior therapy are usually highly prognostic, and therefore, it is important to weigh the eligibility criteria carefully, as these parameters will define the population for which findings may pertain. This is particularly important, as in most phase II trials the observed level of activity will be compared not to a concurrent control group, but rather to a historical probability of response to standard treatment for patients presumed to be comparable in terms of stage of disease, performance status, and other characteristics.

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