{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"43.9","value":"3.1781"},{"groupId":"OG001","spread":"8.0","value":"2.4581"},{"groupId":"OG002","spread":"32.8","value":"2.9060"},{"groupId":"OG003","spread":"136.6","value":"1.7521"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"title":"Eribulin"},{"categories":[{"measurements":[{"groupId":"OG002","spread":"23.2","value":"27.27"},{"groupId":"OG003","spread":"60.7","value":"30.30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"title":"Irinotecan"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"description":"CL for irinotecan could not be estimated for phase 1:schedule A, eribulin mesilate 1.4 mg/m\\^2 + irinotecan 20 mg/m\\^2 and phase 1: schedule A, eribulin mesilate 1.4 mg/m\\^2 + irinotecan 40 mg/m\\^2 arm because it was not possible to calculate half-life as the slope of the terminal phase of the concentration-time profiles could not be determined.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG000","title":"Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2"},{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG001","title":"Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2"},{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2 and irinotecan hydrochloride 100 mg/m\\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG002","title":"Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2"},{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2 and irinotecan hydrochloride 125 mg/m\\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG003","title":"Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration. Here 'N' (overall number of participants analyzed) included all participants who were evaluable for this outcome measure and 'n' (number analyzed) included all participants who were evaluable for each category.","reportingStatus":"POSTED","timeFrame":"For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)","title":"Phase 1, Total Clearance (CL) of Eribulin and Irinotecan","type":"SECONDARY","unitOfMeasure":"liter per hour (L/h)"}