{"denoms":[{"counts":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"51"},{"groupId":"BG005","value":"52"},{"groupId":"BG006","value":"50"},{"groupId":"BG007","value":"173"}],"units":"Participants"}],"groups":[{"description":"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.","id":"BG000","title":"Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus"},{"description":"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.","id":"BG001","title":"Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus"},{"description":"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.","id":"BG002","title":"Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus"},{"description":"The DLT was achieved and no participants were enrolled into this cohort.","id":"BG003","title":"Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus"},{"description":"Oral lenvatinib (18 mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.","id":"BG004","title":"Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus"},{"description":"Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.","id":"BG005","title":"Phase 2 (Arm B): 24 mg Lenvatinib"},{"description":"Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.","id":"BG006","title":"Phase 2 (Arm C): 10 mg Everolimus"},{"description":"Total of all reporting groups","id":"BG007","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"3.92","value":"58.0"},{"groupId":"BG001","spread":"7.97","value":"58.1"},{"groupId":"BG002","spread":"2.83","value":"61.0"},{"groupId":"BG004","spread":"0","value":"0"},{"groupId":"BG005","spread":"0","value":"0"},{"groupId":"BG006","spread":"0","value":"0"},{"groupId":"BG007","spread":"6.29","value":"58.4"}]}],"title":"Phase 1b"},{"categories":[{"measurements":[{"groupId":"BG000","spread":"0","value":"0"},{"groupId":"BG001","spread":"0","value":"0"},{"groupId":"BG002","spread":"0","value":"0"},{"groupId":"BG004","spread":"8.2","value":"61.7"},{"groupId":"BG005","spread":"8.6","value":"63.3"},{"groupId":"BG006","spread":"9.2","value":"58.9"},{"groupId":"BG007","spread":"8.8","value":"61.3"}]}],"title":"Phase 2"}],"dispersionType":"STANDARD_DEVIATION","paramType":"GEOMETRIC_MEAN","title":"Age, Customized","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG004","value":"16"},{"groupId":"BG005","value":"13"},{"groupId":"BG006","value":"12"},{"groupId":"BG007","value":"47"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"1"},{"groupId":"BG004","value":"35"},{"groupId":"BG005","value":"39"},{"groupId":"BG006","value":"38"},{"groupId":"BG007","value":"126"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"}],"populationDescription":"Full analysis set included all randomized participants."}