{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Maximum serum concentration (Cmax) of Sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with AML and FLT3-ITD mutation.","groups":[{"description":"Patients receive sorafenib as in stratum 1 at the MTD determined in stratum 2. Patients undergo blood sample collection for pharmacokinetics, pharmacodynamics (in leukemia blasts only), circulating endothelial cells (CEC), circulating CEC precursors (CECP), VEGF and VEGF-2 , gene expression, proteomic profile, ERK phosphorylation, and FLT3 phosphorylation activity. Tumor tissue samples may also be analyzed for the presence of ras, raf, or FLT3.","id":"OG000","title":"STRATUM III (ACUTE MYELOID LEUKEMIA AND FLT3-ITD MUTATION)"}],"populationDescription":"Data was and never will be collected","reportingStatus":"POSTED","timeFrame":"8 hours post dose on day 1 of cycle 1","title":"Maximum Serum Concentration (Cmax) of Sorafenib","type":"PRIMARY"}