A -- PHASE I CLINICAL STUDIES OF CHEMOPREVENTIVE AGENTS

Notice Date

July 16, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Room 608G, Rockville, MD, 20852

ZIP Code

20852

Solicitation Number

N01-CN-85080-39

Response Due

October 15, 2001

Point of Contact

Cynthia Washington, Contract Specialist, Phone (301) 435-3798, Fax (301) 402-8579, Email cw212f@nih.gov -- Gary Topper, Contracting Officer, Phone (301) 435-3793, Fax (301) 402-8579, Email gt22b@nih.gov

Description

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 (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 a non-monetary and is exclusively for the purpose of compiling a pool of contractors who are pre-qualified 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 date for receipt of proposals of October 15 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://rcb.nci.nih.gov/. Click on "Current Request for Proposals." 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. All request should be referenced the RFP No. N01-CN-85080-39. No collect calls will be accepted.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/RCB/N01-CN-85080-39/listing.html)

Record

Loren Data Corp. 20010718/ASOL005.HTM (D-197 SN50R9D0)