The overall goal of this proposal is to provide a resource to the OSU UM1 (P.I. Michael Grever) for the conduct of Phase 2 clinical trials of National Cancer Institute (NCI) sponsored agents, to evaluate biologic effects of these agents on their molecular targets, to evaluate other relevant biologic effects, and to determine clinical relevant outcomes/correlates of efficacy and toxicity. The Ohio State University NCI-designated Comprehensive Cancer Center (OSUCCC) and its affiliated hospitals and clinics generate a resource of more than 5600 new analytic cancer patients per year. For this supplement proposal, the OSUCCC is partnering with other large cancer research and treatment centers in the State of Ohio: Seidman Cancer Center of University Hospitals Case Medical Center and The Cleveland Clinic Taussig Cancer Institute, consortium members of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University (another 10,000 analytic new cancer patients per year) and the newly NCI-designated Markey Cancer Center (MCC) at the University of Kentucky (UK). With the latter institution that provides geographical proximity, we can now provide patients the opportunity for Phase 2 trials in a contiguous region (Ohio-Kentucky-West Virginia corridor) with access to novel therapeutics. It importantly incorporates a heavily underserved and special population (patients from the Central Appalachian Region) to the biological and therapeutic evaluation of novel targets. Access to a top rated school of pharmacy at UK, now strengthens further our translational science expertise.
Phase 2 trials are arguably the most important type of clinical trials in the development of new anticancer agents. The decision of developing them further is often made during this phase. Important questions regarding safety, and if the drug hits the target that they are supposed to, are best evaluated in this trial phase. The current proposal will extend the capability of the OSU Early Therapeutics Clinical Network (ETCTN) UM1 grant (P.I. M Grever) which is Phase 1 based to perform Phase 2 trials with ETCTN novel agents in development. The consortium proposed include the two NCI designated Comprehensive Cancer Centers in the State of Ohio and a newly NCI designated cancer center in close proximity (Markey Cancer center, University of Kentucky). Together, we will bring the evaluation of novel agents to two states with high burden of cancer and to the disadvantaged populations of central Appalachia. Exceptional track record in translational science, research imaging and pharmacoanalytics will be leveraged during the conduct of this program.
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