Task I: Single-dose Pharmacokinetic Study The Contractor shall develop a single-dose, phase 1 clinical protocol for Limonene in Patients with a Prior History of Breast Carcinoma to evaluate the parameters of drug absorption, plasma concentration-time profiles, distribution (in relevant tissues, where feasible), excretion, and toxicity. 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. Task II: Multiple-dose Safety & 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.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN055131-002
Application #
2557649
Study Section
Project Start
1995-06-30
Project End
1998-06-29
Budget Start
1997-06-02
Budget End
1998-06-29
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Type
DUNS #
017730458
City
Cleveland
State
OH
Country
United States
Zip Code
44195
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Huguley Jr, C M (1987) Screening for breast cancer. J Med Assoc Ga 76:310-3