The contractor shall develop a multiple-dose safety and pharmacokinetic phase 1 clinical protocol for sulindac sulfone to evaluate the parameters of safety and toxicity and of steady-state pharmacokinetics in patients with APC. In addition, investigations of pharmacological and/or cancer surrogate endpoint biomarker modulation (e.g. changes in existing polyps) are encouraged. The proprietary sulindac sulfone compound, also known as FGN-1, is the subject of a Clinical Trials Agreement between the National Cancer Institute, Division of Cancer Prevention and Control and Cell Pathways, Inc. Protocol activation 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 hold the IND.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN055119-000
Application #
2302626
Study Section
Project Start
1995-06-30
Project End
1996-06-29
Budget Start
1995-06-30
Budget End
1996-06-29
Support Year
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Type
DUNS #
017730458
City
Cleveland
State
OH
Country
United States
Zip Code
44195