PHASE I STUDIES OF CHEMOPREVENTIVE AGENTS NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFP AVAILABLE: N01CN75079-70 P.T.34 Keywords: Cancer/Carcinogenesis Chemopreventive Agents National Cancer Institute 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 several 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 award of 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. Numbered Note 26 - Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. Erin C. Lange Research Contracts Branch, PCCS National Cancer Institute 6120 Executive Boulevard, Room 635 Bethesda MD 20892-7226 Telephone: (301) 435-3828 .
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