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

A -- PHASE I CLINICAL STUDIES OF CHEMOPREVENTIVE AGENTS SOL N01-CN-85080-70 POC Erin C. Lange, Contracting Officer, 301-435-3828 WEB: Research Contracts and Acquisition Branch Current Requests, http://deaxtra.nci.nih.gov/awards/rfps_published.asp. E-MAIL: Erin C. Lange, el45g@NIH.gov. The Chemoprevention Branch of the Division of Cancer Prevention (DCP), National Cancer Institute (NCI), National Institutes of Health (NIH), is expanding the existing 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. Master Agreements will be awarded to all respondents whose technical proposal is considered acceptable. The Master Agreement award is non-monetary and is exclusively for the purpose of compiling a pool of contractors who are pre-qualified to perform services to perform specific Phase I studies. Each Master Agreement holder will be eligible to compete for future contract awards to carry out specific Phase I studies. Master Agreement holders receiving a contract award will be selected through this pool, based on technical merit and on budgetary considerations for specific tasks involved. Any MA awarded as a result of this solicitation will be in effect from the effective date to February 15, 2003. This solicitation will be open for the duration of the existing MA pool with due dates for receipt of proposals semi-annually, June 1 and December 1 (or the next business day) of each year. All responsible sources meeting these criteria are encouraged to submit a proposal and a sample requirement to be considered by the NCI. ALL MASTER AGREEMENT HOLDERS ALREADY IN THE EXISTING MASTER AGREEMENT POOL NEED NOT RESPOND TO THIS ANNOUNCEMENT. The RFP may be accessed through the Research Contracts Branch Home Page by using the following Internet address: http://deaxtra.nci.nih.gov/awards/rfps_published.asp. 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, Contracting Officer, NCI, RCB, PCPSS; 6120 Executive Boulevard, Executive Plaza South, Room 635, Rockville, MD 20852; Phone: 301-435-3828;. Fax: (301) 402-8579. Electronic mail address: el45g@nih.gov. All requests should reference the RFP No. N01-CN-85080-70. No collect calls will be accepted. See Numbered Note 26. Posted 03/23/99 (W-SN311394). (0082)

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