{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"60"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"MTD defined as the highest dose level with \\</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during the first 28 days of treatment.","groups":[{"description":"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.\n\nPhase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.\n\nPhase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.\n\nSelinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.\n\nPhase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.\n\nSorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.\n\nPhase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.","id":"OG000","title":"Phase I Group 1 Selinexor + Sorafenib"},{"description":"Cohort includes those with FLT3-ITD and -D835 mutated participants with relapsed/refractory AML, including participants who may have been previously exposed to one or more FLT3-inhibitors.\n\nPhase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.\n\nPhase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle. Phase I Group 2 received Selinexor 80 mg by mouth twice weekly for a 28 day cycle.","id":"OG001","title":"Phase I Group 2 Selinexor + Sorafenib"},{"description":"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.\n\nPhase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.\n\nPhase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.\n\nSelinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.\n\nPhase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.\n\nSorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.\n\nPhase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.","id":"OG002","title":"Cohort 1 (FLT3-ITD Inhibitor Failure Cohort)"},{"description":"Cohort includes those with FLT3-ITD and -D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens.\n\nPhase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.\n\nPhase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.\n\nSelinexor: Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.\n\nPhase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I.\n\nSorafenib: Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.\n\nPhase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I.","id":"OG003","title":"Cohort 2 (FLT3-ITD Inhibitor Naive Cohort)"}],"paramType":"NUMBER","populationDescription":"The Outcome Measure of MTD was the objective of the Phase I Selinexor + Sorafenib cohort only. Data for MTD were not collected for patients on Cohorts 1 and 2.","reportingStatus":"POSTED","timeFrame":"28 days","title":"Maximum Tolerated Dose (MTD) of Selinexor With Sorafenib","type":"PRIMARY","unitOfMeasure":"Milligrams"}