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U.S. National Institutes of Health
Last Updated: 05/06/13

Phase 1-2 Early Drug Development

The CTEP Early Drug Development Program (EDDP), under the direction of the Investigational Drug Branch, carries out drug development plans for investigational agents held under CTEP IND, in collaboration with industry, academia, and the NCI intramural program. CTEP currently holds approximately 80 active INDs, with more than 500 phase 1-2 clinical trials. The primary funded components of the CTEP EDDP include the Phase 1 U01 grantees and the Phase 2 N01 contractors. The 14 Phase 1 U01s carry out a range of clinical trials with investigational agents to determine their safety and tolerability and their pharmacokinetic behavior. These trials range from first-in-man studies, to exploration of different doses and schedules of administration and investigational agent combinations. In addition, the Organ Dysfunction Group carries out trials to determine appropriate doses of investigational agents in patients with compromised hepatic and renal function.

The 9 Phase 2 N01 Contractors, many of whom are constituted as multi-institutional consortia, carry out clinical trials of investigational agents, alone and in combination, to ascertain whether these therapies may provide clinical benefit. In addition, both the U01 and N01 investigators carry out studies to explore the biological effects of investigational agents upon tumor and other patient tissues. These studies may include analyses performed on patient samples as well as functional imaging.

Other sites that carry out clinical trials with CTEP IND agents include the Cooperative Groups, cancer centers, and the NCI intramural program.