{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Half-life 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":"Half-life of Sorafenib","type":"PRIMARY"}