National Cancer Institute, Research Contracts Branch, PCCS, 6120 Executive Blvd, Room 635, Bethesda, MD 20892-7226

A -- PHASE II-CLINICAL TRIALS OF NEW CHEMOPREVENTIVE AGENTS SOL MAA-N01-CN-75023-82 DUE 070797 POC Michelle L. Scala, Contract Specialist E-MAIL: Michelle L. Scala, scalam@rcb.nci.nih.gov. The National Cancer Institute, Division of Cancer Prevention and Control (DCPC), Chemoprevention Branch is interested in establishing a Master Agreement pool with the objective of encouraging cancer chemoprevention clinical trails that use biochemical and biological markers as intermediate endpoints. The application of biological markers to clinical prevention trials carries great promise in relation to ultimate cancer prevention. When cancer incidence reduction itself is used as an endpoint in studies of this type, a very large number of subjects tested for long durations is often required. The design of phase 2a clinical trials will be small, short-term, efficient studies that determine the dose-response of a given chemopreventive agent on pharmacological and intermediate endpoints, the minimum dose at which this biological effect is observed, and the maximum safe dose. The second segment phase 2b study will involve a randomized, placebo-controlled, blinded trial in a small group of subjects in whichthe endpoint will be a modulation of a quantifiable biological effect that is correlated with cancer incidence reduction in the agent versus the placebo treated groups. This acquisition is for a five year Master Agreement. MAA/RFP N01-CN-75023-82 will be available electronically on or about April 28, 1997, and may be accessed through the NCI/RCB Website at http://wwwrcb.nci.nih.gov/ Following proposal submission and the initial technical review process, offerors whose proposals were judged ACCEPTABLE will be awarded an MA; they will then be eligible to compete for work as Master Agreement Order (MAO) RFP's are issued. Responses to the MAA/RFP will be due on or about July 7, 1997. Point of contact: Michelle L. Scala, Contract Specialist; Electronic mail address: scalam@rcb.nci.nih.gov; Telephone: (301) 435-3829; Fax: (301) 402-8579. All requests should reference N01-CN-75023-82. All responsible sources may submit a proposal, which shall be considered by the agency. No collect calls will be accepted. See NUMBERED NOTES: Note 26 (0098)

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