The Phase I Program of the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center (UWCCC) has been consistently performing high quality phase I drug development studies sponsored by the NCI since 1979. As a result, we have played an active role in the evolution of early drug development and built the foundation to help set the standard for the delivery of individualized cancer care in the future. This application represents the renewal of U01 CA062491. Our Phase I Program continues to emphasize the tradition of excellence in clinical trials established in 1979 with a commitment to: 1) support the diverse array of preclinical research being performed at the UWCCC;2) provide a stable infrastructure devoted to clinical research;3) maintain an outstanding group of clinical investigators who perform high quality trials;and 4) promote the interactions between experts throughout the UWCCC and campus. This application details our experience in NCI-sponsored drug development studies over the last grant period and also describes the methods by which we performed these studies. Our current and future objectives are: Objective 1: Conduct of targeted early phase clinical trials Objective 2: Assessment of pharmacokinetics to establish dose, schedule, exposure and effect relationships Objective 3: Explore novel paradigms and designs for the evaluation of new agents Objective 4: Study special populations in early phase clinical trial Objective 5: Establish safe and biologically active treatment schedules for novel agents Objective 6: Determine mechanistic proof of principle data for new molecularly targeted agents Objective 7: Evaluate combinations of CTEP IND agents to assess the nature of drug-drug interactions Objective 8: Evaluation of translational endpoints in clinical trials of investigational agents The UWCCC accrues an average of 535 patients per year to early-phase clinical trials (phase I and II), of which 225 are on phase I trials. This strong track record for early-phase clinical trials accrual assures that the Phase I Program has the capability to meet CTEP U01 accrual expectations of 50 patients per year. During the current grant period, the Phase I Program addressed all of the objectives noted above and accrued an average of 54 patients to approved U01 early phase clinical trials annually. While all Phase I Program UO1 trials had translational endpoints, correlative studies of seven of these trials received CTEP-TRI funding.
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