{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 3 abdominal pain"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 2 fatigue with Grade 1 GI reflux & anorexia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Grade 3 nausea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}],"title":"Grade 2 stomatitis"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}],"units":"Participants"}],"description":"A DLT was defined as either a treatment-related failure to administer greater than or equal to (\\>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) \\>= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly related to lenvatinib and/or everolimus therapy assessed during the first treatment cycle of each dose level. Higher grade indicates more severe toxicity.","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":"OG000","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":"OG001","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 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":"OG002","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":"OG003","title":"Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus"},{"description":"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken 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":"OG004","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":"OG005","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":"OG006","title":"Phase 2 (Arm C): 10 mg Everolimus"}],"paramType":"NUMBER","populationDescription":"Safety analysis set included all participants who received at least one dose of study treatment.","reportingStatus":"POSTED","timeFrame":"First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)","title":"Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}