{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.8","upperLimit":"24.7","value":"18.8"},{"groupId":"OG001","lowerLimit":"10.6","upperLimit":"23.3","value":"20.8"},{"groupId":"OG002","lowerLimit":"13.2","upperLimit":"25.4","value":"18.9"},{"groupId":"OG003","lowerLimit":"13.8","upperLimit":"23.3","value":"17.5"},{"groupId":"OG004","lowerLimit":"10.2","upperLimit":"22.1","value":"17.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"}],"units":"Participants"}],"description":"Median (Range) for the rate of elimination of the drug by dose level stratified by study part and dose level.","dispersionType":"Full Range","groups":[{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Part A Dose Level 1: 15 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Part A Dose Level 2: 20 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Part A Dose Level 3: 25 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Part A Dose Level 4: 35 mg/m^2"},{"description":"Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG004","title":"Part A PK Dose Level 4: 35 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"All eligible patients with data collected","reportingStatus":"POSTED","timeFrame":"Up to 10 days","title":"Clearance of Pevonedistat in Combination With Irinotecan and Temozolomide","type":"PRIMARY","unitOfMeasure":"L/hr/m^2"}