NIH GUIDE, Volume 26, Number 25, August 1, 1997







  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:  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


AMENDMENTS.  Point of contact: Erin C. Lange.  Electronic mail

address:  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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