Nilotinib Phase II Trial Planning Committee Activities

Project: Research project

Project Details

Description

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
StatusFinished
Effective start/end date10/1/167/6/17

Funding

  • The Michael J Fox Foundation for Parkinson's Research (Letter 10/19/16)

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