The summary for the Pediatric Phase 1/Pilot Consortium (U01) Federal Grant is detailed below.
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Additional Information on Eligibility
Foreign institutions are not eligible to apply. The eligibility to apply in response to this limited competition RFA is limited to the current recipient of the Children s Oncology Group Phase 1/Pilot Consortium award under U01 CA097452.
The purpose of the Request for Applications (RFA) reissuance is to continue NCI s program for the development of new anticancer agents for pediatric patients through the Children s Oncology Group (COG) Phase 1/Pilot Consortium. The Consortium will be responsible for timely conduct of the Phase 1 and pilot studies that are essential to NCI s overall clinical research program for children with cancer. This limited competition RFA for the renewal of U01 CA097452 solicits a single application from the Phase 1/Pilot Consortium of the Children s Oncology Group (COG) to continue its drug development activities. The specific objectives for the Consortium in the anticipated 5-year funding period will be: to safely and efficiently introduce novel anticancer agents into the pediatric setting through the conduct of Phase 1 clinical trials; to collaborate with COG Disease Committees to develop and conduct pilot studies of promising new treatment approaches for children with specific types of cancer; and to incorporate pharmacokinetic and pharmacodynamic endpoints (including imaging and translational laboratory studies) as appropriate into Phase 1 and pilot studies to facilitate future development of the new treatment approaches.