PHASE I CLINICAL STUDIES OF CHEMOPREVENTIVE AGENTS

Release Date:  April 1, 1999

RFP AVAILABLE:  N01-CN-85080-70

P.T.

National Cancer Institute

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://www.peacetech.com/rcab/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.

INQUIRIES

All requests should reference RFP No. N01-CN-85080-70.  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. 

Point of contact

Erin C. Lange
Research Contracts Branch
National Cancer Institute
6120 Executive Boulevard, Room 635
Rockville, MD  20852
Telephone:  (301) 435-3828
FAX:  (301) 402-8579
Email:  el45g@nih.gov

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