Figure 1: Treatment Algorithm

DLT is defined as 1 of the following events deemed to be at least possibly related to study drug: 1) grade III toxicity or above (would encompass life-threatening events); 2) liver function abnormalities as defined in protocol; or 3) other events clinically judged to necessitate dose reductions. If a DLT occurs in the dose reduction step, the decision on whether to stop the study or to continue (reducing the dose by 1 additional dose level) will be made by sponsor and the principal investigator in consultation with the DSMB. DLT = dose-limiting toxicity; DSMB = Data Safety Monitoring Board; GGF = glial growth factor; PBO = placebo.



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