{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.2","upperLimit":"130","value":"57.2"},{"groupId":"OG001","lowerLimit":"24.4","upperLimit":"121","value":"72.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"description":"Clearance 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 refractory solid tumors or leukemias.","dispersionType":"Full Range","groups":[{"description":"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). Once the MTD is determined, up to 6 additional patients under 12 years of age may be treated at the MTD. The MTD dose level is also expanded to enroll up to 6 patients with refractory leukemia.","id":"OG000","title":"STARTUM I (REFRACTORY SOLID TUMORS)"},{"description":"A cohort of 3-6 patients with leukemia receives treatment as in stratum 1 at the MTD determined in stratum 1. If 2 of 3 or 2 of 6 patients experience a DLT at the solid tumor MTD, sorafenib is reduced by one dose level. The leukemia MTD is defined as the dose at which \\< 1/3 of patients experience DLT during course 1 of treatment.","id":"OG001","title":"STRATUM II (REFRACTORY LEUKEMIA)"}],"paramType":"MEAN","populationDescription":"Pharmacokinetic (PK) studies were completed for stratums I and II. Summary statistics for PK analysis was performed regardless of dose level as pre-specified in the protocol. PK was not performed in stratum III","reportingStatus":"POSTED","timeFrame":"During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose","title":"Clearance (Cl) of Sorafenib","type":"PRIMARY","unitOfMeasure":"mL/min/m^2"}