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

A -- PHASE I STUDIES OF CHEMOPREVENTIVE AGENTS SOL NO1-CN-75079-70 DUE 101597 POC Erin C. Lange, Contracting Officer, 301/435-3828 WEB: Research Contracts Branch RFP Page, http://wwwrcb.nci.nih.gov/rfp.htm. E-MAIL: Erin C. Lange, langee@rcb.nci.nih.gov. ELECTRONIC RFP ANNOUNCEMENT. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. The Chemoprevention Branch of the Division of Cancer Prevention and Control, National Cancer Institute, is interested in establishing a Master Agreement pool with the objective of conducting phase I clinical trials to evaluate the pharmacokinetics, pharmacology, and toxicology of chemopreventive agents, as well as to evaluate the modulation of biological markers of carcinogenesis. 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 1a clinical trials will be small, single- dose, efficient studies that determine the dose-response of a given chemopreventive agent on pharmacokinetics, pharmacology, and toxicology. The second segment, phase 1b study, will involve a sequential, short-term (3-6 month), dose-escalation trial (in some cases randomized, placebo-controlled, and blinded) in a small group of subjects in which the endpoints will be pharmacokinetics, pharmacology, toxicology, and exploration of the modulation of quantifiable biological effects that are correlated with cancer incidence reduction. The maximum tolerated dose and the minimum effective dose will be determined. The Master Agreement Announcement (MAA) is scheduled for electronic release on/about August 8, 1997 with proposals due on October 15, 1997. It is estimated that multiple Master Agreements will be awarded as a result of this announcement, each having a sixty month period of performance. The Master Agreement (MA) contract mechanism is a prequalification to enable qualified sources to compete for and perform future Master Agreement Orders (MAOs). The MA itself is unfunded. The obligation of funds shall be accomplished solely through the awardof Master Agreement Orders (MAOs). It is estimated that approximately five (5) MAOs will be awarded per year. The RFP may be accessed through the Research Contracts Branch Home Page by using the following Internet address: http://wwwrcb.nci.nih.gov/rfp.htm. It is the offerors responsibility to monitor the above Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Erin C. Lange. Electronic mail address: langee@rcb.nci.nih.gov. Fax: (301) 402-8579. No collect calls will be accepted. See Numbered Note 26. (0197)

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