{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.25","upperLimit":"6.00","value":"3.2"},{"groupId":"OG001","lowerLimit":"1.08","upperLimit":"23.8","value":"3.2"},{"groupId":"OG002","lowerLimit":"1.00","upperLimit":"6.00","value":"2.0"},{"groupId":"OG003","lowerLimit":"2.98","upperLimit":"8.20","value":"3.0"},{"groupId":"OG004","lowerLimit":"2.03","upperLimit":"8.23","value":"3.5"},{"groupId":"OG005","lowerLimit":"1.00","upperLimit":"7.17","value":"3.1"},{"groupId":"OG006","lowerLimit":"2.37","upperLimit":"8.00","value":"6.0"},{"groupId":"OG007","lowerLimit":"1.03","upperLimit":"24.0","value":"4.0"},{"groupId":"OG008","lowerLimit":"3.00","upperLimit":"6.00","value":"4.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"17"},{"groupId":"OG008","value":"3"}],"units":"Participants"}],"description":"To characterize the preliminary pharmacokinetics including T max of X-396 given as a single agent","dispersionType":"Full Range","groups":[{"description":"Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG000","title":"Phase I: X-396 (Ensartinib) at 25mg"},{"description":"RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.\n\nPhase II: X-396 (ensartinib): Expanded Cohort","id":"OG001","title":"Phase II: X-396 (Ensartinib) at 225 mg (Fasted)"},{"description":"Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG002","title":"Phase I: X-396 (Ensartinib) at 50 mg"},{"description":"Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG003","title":"Phase I: X-396 (Ensartinib) at 100 mg"},{"description":"Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.\n\nNumber of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG004","title":"Phase I: X-396 (Ensartinib) at 200 mg (Fasted)"},{"description":"Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG005","title":"Phase I: X-396 (Ensartinib) at 250mg"},{"description":"Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG006","title":"Phase I: X-396 (Ensartinib) at 225mg"},{"description":"RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.\n\nPhase II: X-396 (ensartinib): Expanded Cohort","id":"OG007","title":"Phase II: X-396 (Ensartinib) at 225 mg (Fed)"},{"description":"Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.\n\nNumber of Cycles: until progression or unacceptable toxicity develops\n\nPhase I: X-396 (ensartinib): Oral, ALK inhibitor","id":"OG008","title":"Phase I: X-396 (Ensartinib) at 200 mg (Fed)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"24 hours","title":"Plasma Tmax on Day 1","type":"SECONDARY","unitOfMeasure":"hour"}