PHASE I STUDIES OF NEW CHEMOPREVENTIVE AGENTS

NIH GUIDE, Volume 23, Number 16, April 29, 1994



MAA AVAILABLE:  NCI-CN-45582-41



P.T. 34



Keywords:

  Cancer/Carcinogenesis 

  Chemopreventive Agents 



National Cancer Institute



The National Cancer Institute (NCI), Division of Cancer Prevention

and Control (DCPC), Chemoprevention Branch, in its annual requirement

to seek new sources, is soliciting proposals for Master Agreement

Holders for the Phase I Studies of New Chemopreventive Agents.  The

objective of these studies is to determine the parameters and

characteristics of toxicity in humans, the safely delivered dose, and

the basic clinical pharmacokinetics of agents emerging from the NCI

chemoprevention agent program so that subsequent Phase III risk

reduction trials can be appropriately designed.  The Master Agreement

Holder will develop and conduct the following Task I and Task II

studies:  Task I: Phase I Studies - Phase I studies will provide the

parameters and characteristics of drug toxicity, the safely delivered

dose and a recommended Phase II/III dose.  Phase I clinical studies

with combinations of agents may be performed if mutually agreed upon

by the Contractor and the Project Officer.  TASK II:  Pharmacokinetic

Studies - Pharmacokinetic studies will provide the parameters of drug

absorption, blood concentration--time profiles, distribution and

excretion.  Using classical and non-classical modeling, the

pharmacokinetic data will be used to determine probable patterns of

distribution, and excretion, compartmentalization and enterohepatic

recirculation, and to include identification as well as distribution

and excretion of metabolites.  The Master Agreement (MA) shall

certify a holder's qualification to compete for both Task I and II.

For a given agent tested, qualifications to carry out both Task I and

II must exist, although only Task II may be required.  A maximum of

ten task orders (including both Tasks I and II), requiring

approximately 200 subjects, will be issued annually for a period of

four years for studies on specific agents.



INQUIRIES



Requests for this solicitation must be in writing and reference

Master Agreement Announcement (MAA) No. NCI-CN-45582-41.  The MAA

will be available approximately May 7, 1994 and due approximately

June 27, 1994.  Requests are to be addressed to:



Ms. Susan K. Hoffman

Research Contracts Branch

National Cancer Institute

Executive Plaza South, Room 635

Bethesda, MD  20892

Telephone:  (301) 496-8603



.

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