PHASE I STUDIES OF NEW CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 23, Number 16, April 29, 1994 MAA AVAILABLE: NCI-CN-45582-41 P.T. 34 Keywords: Cancer/Carcinogenesis Chemopreventive Agents National Cancer Institute The National Cancer Institute (NCI), Division of Cancer Prevention and Control (DCPC), Chemoprevention Branch, in its annual requirement to seek new sources, is soliciting proposals for Master Agreement Holders for the Phase I Studies of New Chemopreventive Agents. The objective of these studies is to determine the parameters and characteristics of toxicity in humans, the safely delivered dose, and the basic clinical pharmacokinetics of agents emerging from the NCI chemoprevention agent program so that subsequent Phase III risk reduction trials can be appropriately designed. The Master Agreement Holder will develop and conduct the following Task I and Task II studies: Task I: Phase I Studies - Phase I studies will provide the parameters and characteristics of drug toxicity, the safely delivered dose and a recommended Phase II/III dose. Phase I clinical studies with combinations of agents may be performed if mutually agreed upon by the Contractor and the Project Officer. TASK II: Pharmacokinetic Studies - Pharmacokinetic studies will provide the parameters of drug absorption, blood concentration--time profiles, distribution and excretion. Using classical and non-classical modeling, the pharmacokinetic data will be used to determine probable patterns of distribution, and excretion, compartmentalization and enterohepatic recirculation, and to include identification as well as distribution and excretion of metabolites. The Master Agreement (MA) shall certify a holder's qualification to compete for both Task I and II. For a given agent tested, qualifications to carry out both Task I and II must exist, although only Task II may be required. A maximum of ten task orders (including both Tasks I and II), requiring approximately 200 subjects, will be issued annually for a period of four years for studies on specific agents. INQUIRIES Requests for this solicitation must be in writing and reference Master Agreement Announcement (MAA) No. NCI-CN-45582-41. The MAA will be available approximately May 7, 1994 and due approximately June 27, 1994. Requests are to be addressed to: Ms. Susan K. Hoffman Research Contracts Branch National Cancer Institute Executive Plaza South, Room 635 Bethesda, MD 20892 Telephone: (301) 496-8603 .
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