CLINICAL DEVELOPMENT OF ANTICANCER AGENTS

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The objective of this contract is to provide the NCI with the Phase I, Pharmacokinetic and Phase II/III clinical evaluations of investigational new drugs. Specifically the Contractor shall 1) define the acute toxicities of new anticancer agents in patients with advanced cancer; 2) define the dose of each agent which can be safely given in subsequent Phase II studies of drug activity; 3) provide information on the pharmacologic characteristics (absorption, distribution, metabolism and elimination) of selected antitumor agents; 4) explore the potential uses of pharmacokinetic analysis for optimizing scheduling and dose escalation procedures in a Phase I trial; 5) determine the spectrum of activity of new agents across a variety of human cancers in patients with minimal prior therapy; and 6) establish the role of a new compound, alone or in combination, in selected human cancers compared to standard therapy.