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.
