{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"250"},{"groupId":"OG002","value":"250"},{"groupId":"OG003","value":"250"},{"groupId":"OG004","value":"250"},{"groupId":"OG005","value":"250"},{"groupId":"OG006","value":"250"},{"groupId":"OG007","value":"250"},{"groupId":"OG008","value":"250"},{"groupId":"OG009","value":"250"},{"groupId":"OG010","value":"250"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"9"}],"units":"Participants"}],"description":"RP2D was defined as a dose below or equal to MTD, at which crizotinib was unlikely to cause a significant inhibition of CYP3A4 activity.","groups":[{"description":"Participants received Crizotinib 50 milligram (mg) capsule or tablet orally once daily (QD) for up to 34 cycles (each cycle 28 days).","id":"OG000","title":"Low Dose Escalation Cohort: Crizotinib 50 mg QD"},{"description":"Participants received Crizotinib 100 mg capsule or tablet orally QD for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 100 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.","id":"OG001","title":"Low Dose Escalation Cohort: Crizotinib 100 mg QD"},{"description":"Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally QD for up to 34 cycles (each cycle 28 days).","id":"OG002","title":"Low Dose Escalation Cohort: Crizotinib 200 mg QD"},{"description":"Participants received Crizotinib 200 mg (2 capsules/tablet of 100 mg each) capsule/tablet orally twice daily (BID) for up to 34 cycles (each cycle 28 days).","id":"OG003","title":"Low Dose Escalation Cohort: Crizotinib 200 mg BID"},{"description":"Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet BID for up to 34 cycles (each cycle 28 days).","id":"OG004","title":"Low Dose Escalation Cohort: Crizotinib 250 mg BID"},{"description":"Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet orally BID for up to 34 cycles (each cycle 28 days) and 2 mg oral dose of Midazolam along with Crizotinib 300 mg on Cycle 2 Day 1 only. Participants who did not receive Crizotinib on Day -7, received single 2 mg oral dose of Midazolam on Day -7.","id":"OG005","title":"Low Dose Escalation Cohort: Crizotinib 300 mg BID"},{"description":"Participants received Crizotinib 300 mg (3 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG006","title":"High Dose Escalation Cohort: Crizotinib 300 mg QD"},{"description":"Participants received Crizotinib 400 mg (4 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG007","title":"High Dose Escalation Cohort: Crizotinib 400 mg QD"},{"description":"Participants received Crizotinib 500 mg (5 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG008","title":"High Dose Escalation Cohort: Crizotinib 500 mg QD"},{"description":"Participants received Crizotinib 650 mg (6 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) for up to 7 cycles (each cycle 28 days).","id":"OG009","title":"High Dose Escalation Cohort: Crizotinib 650 mg QD"},{"description":"Participants received Crizotinib 800 mg (8 capsules/tablet of 100 mg each) capsule/tablet QD for up to 7 cycles (each cycle 28 days).","id":"OG010","title":"High Dose Escalation Cohort: Crizotinib 800 mg QD"}],"paramType":"NUMBER","populationDescription":"Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (28 days)","title":"Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib","type":"PRIMARY","unitOfMeasure":"milligram"}