National Cancer Institute, Research Contracts Branch, PCCS, Executive Plaza South, Room 635, Bethesda, MD 20892

A -- PHASE I STUDIES OF NEW CHEMOPREVENTIVE AGENTS SOL NCI-CN-55082-70 DUE 031595 POC Erin C. Lange, Contracting Officer Representative, Susan K. Hoffman, Contracting Officer, 301-496-8603. The National Cancer Institute, 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 development program so that subsequent Phase III risk reduction trials can be appropriately designed. The Master Agreement Holder shall develop and conduct the following Task I and Task II studies: Task I: Phase I Studies - Phase I studies shall 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 shall provide the parameters of drug absorption, blood concentration--time profiles, distribution and excretion. Using classical and non-classical modeling, the pharmacokinetic data shall 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 Tasks 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, shall be issued annually for a period of four (4) years for studies on specific agents. Requests for this solicitation must be in writing and reference Master Agreement Announcement (MAA) No. NCI-CN-55082-70. The Master Agreement Announcement (MAA) will be available approximately February 1, 1995 and due approximately March 15, 1995. Requests should be addressed/mailed to Erin C. Lange, Contracting Officer Representative, National Institutes of Health, National Cancer Institute, Research Contracts Branch, PCCS, Executive Plaza South, Room 635, 6120 Executive Boulevard MSC 7226, Bethesda, Maryland 20892-7226. No collect calls will be accepted. (0010)

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