Nilotinib Phase II Trial Planning Committee Activities

Project Deliverables •Finalize study protocol, budget, and IND application for the Nilotinib Phase IITrial •Identify clinical sites, core facilities, and vendors to participate in the NilotinibPhase II Trial Milestones •Participate in regular teleconferences with other committee members •Finalize the study protocol •Prepare and finalize the study budget •Prepare and submit IND application •Prepare RFPs to solicit bids for oCoordination center oData management center •Prepare RFPs to solicit vendors for oECG oRoutine labs oBiosamples ( PK, biomarkers, etc) processing oSecondary drug distribution •Propose study sites •Transition activities to the DCC and CCC