{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.1"},{"groupId":"OG001","value":"13.8"},{"groupId":"OG002","spread":"28.4","value":"9.83"},{"groupId":"OG003","spread":"20.0","value":"12.8"},{"groupId":"OG004","spread":"23.7","value":"7.76"},{"groupId":"OG005","spread":"33.1","value":"9.50"},{"groupId":"OG006","spread":"28.4","value":"11.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"21"}],"units":"Participants"}],"description":"Pharmacokinetic (PK) parameters were calculated based on trametinib plasma concentrations by using non-compartmental methods. The average steady state plasma concentration (Cavg) of trametinib was calculated as the ratio of area under the curve (AUC)/tau, where tau = 24 h for trametinib.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 50% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (2.63 mg/kg/day for \\<12 years old subjects and 2.25 mg/kg/day for ≥12 years old subjects)","id":"OG000","title":"Part C - TMT 0.025 mg/kg/Day + 50% DRB RP2D"},{"description":"Participants treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG001","title":"Part C - TMT 0.025 mg/kg/Day + 100% DRB RP2D"},{"description":"Participants under 6 years of age treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)","id":"OG002","title":"Part C - TMT 0.032 mg/kg/Day + 100% DRB RP2D"},{"description":"Participants with low grade glioma (LGG) treated with a combination therapy of trametinib (0.032 mg/kg/day for \\< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG003","title":"Part D - LGG"},{"description":"Participants with Langerhans cell histiocytosis (LCH) treated with a combination therapy of trametinib (0.032 mg/kg/day for \\< 6 years old subjects and 0.025 mg/kg/day for ≥ 6 years old subjects) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG004","title":"Part D - LCH"},{"description":"Participants under 6 years of age (all tumor types in Part D) treated with a combination therapy of trametinib (0.032 mg/kg/day) with 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day)","id":"OG005","title":"Part D - All Tumor Types TMT 0.032 mg/kg/Day + 100% DRB RP2D"},{"description":"Participants (all tumor types in Part D) treated with a combination therapy of trametinib (0.025 mg/kg/day) plus 100% of the recommended phase II dose (RP2D) of dabrafenib monotherapy (5.25 mg/kg/day for \\<12 years old subjects and 4.5 mg/kg/day for ≥12 years old subjects)","id":"OG006","title":"Part D - All Tumor Types TMT 0.025 mg/kg/Day + 100% DRB RP2D"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"All subjects who received at least one dose of trametinib in Part C and D and provided an evaluable PK profile with a value for the outcome measure","reportingStatus":"POSTED","timeFrame":"pre dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post trametinib dose on Cycle 1 Day 15. The duration of 1 cycle was 28 days.","title":"Average Steady State Plasma Concentration (Cavg) of Trametinib When Administered in Combination With Dabrafenib","type":"SECONDARY","unitOfMeasure":"ng/mL"}