Figure 1: Treatment Algorithm
2019-06-11T07:02:59Z (GMT) by
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.