{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"81.9","value":"5"},{"groupId":"OG001","spread":"40.0","value":"136"},{"groupId":"OG002","spread":"86.5","value":"29"},{"groupId":"OG003","spread":"57.7","value":"53"},{"groupId":"OG004","spread":"79.8","value":"114"},{"groupId":"OG005","spread":"44.4","value":"182"},{"groupId":"OG006","spread":"44.0","value":"94"},{"groupId":"OG007","spread":"52.7","value":"125"},{"groupId":"OG008","spread":"44.5","value":"109"}]}]}],"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 Cmax f X-396 given as a single agent","dispersionType":"Standard Deviation","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":"GEOMETRIC_MEAN","populationDescription":"Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations.","reportingStatus":"POSTED","timeFrame":"24 hours","title":"Plasma Concentrations Cmax for Day 1","type":"SECONDARY","unitOfMeasure":"ng/ml"}