Task I: Single-dose Pharmacokinetic Study The Contractor shall develop a single-dose, phase 1 clinical protocol for p-XSC to evaluate the parameters of drug absorption, plasma concentration- time profiles, distribution (in relevant tissues, where feasible), excretion, and toxicity. Task II: Multiple-dose Safety and Pharmacokinetic Study The Contractor shall develop a multiple-dose safety and pharmacokinetic phase 1 clinical protocol for the chemopreventive agent to evaluate the parameters of safety and toxicity and of steady-state pharmacokinetics. In addition, investigations of pharmacological and/or cancer surrogate endpoint biomarker modulation may be undertaken, e.g. modulation of apoptosis, PGE2, GSH-Px, or urinary adducts. Protocol activation for Task I and Task II will occur following IRB and FDA approval and the receipt of all chemopreventive drug(s) from the NCI by the Contractor. The Contractor shall submit the protocol to NCI DCPC Protocol Safety and Review Committee for review and comment, address all issues raised in the NCI review, and submit a finalized protocol for IRB approval. The Contractor shall prepare all materials necessary for FDA approval. The NCI will submit the protocol to the FDA and will hod the IND.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN065019-004
Application #
6367920
Study Section
Project Start
1996-09-30
Project End
2001-09-29
Budget Start
2000-09-27
Budget End
2001-09-29
Support Year
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Kansas
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
016060860
City
Kansas City
State
KS
Country
United States
Zip Code
66160