The specific objective of this contract will be to provide the Investigational Drug Branch (IDB), CTEP, DCT, NCI, with Phase I clinical evaluations of investigational new drugs which are developed through the DCT Linear Array and are sponsored to the Food and Drug Administration (FDA) under an IND held by DCT. The objective of Phase I studies is to provide the parameters and characteristics of drug toxicity, the maximally tolerated dose, and a recommended Phase II dose.
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Legha, S S; Tenney, D M; Krakoff, I R (1986) Phase I study of taxol using a 5-day intermittent schedule. J Clin Oncol 4:762-6 |
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