{"groups":[{"description":"• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.","id":"FG000","title":"MM-398 (Arm A)"},{"description":"* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle\n* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.","id":"FG001","title":"5-FU + Leucovorin (Arm B)"},{"description":"* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.\n* 5-FU 2400 mg/m2 IV over 46-hours, and\n* Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks","id":"FG002","title":"MM-398 + 5-FU + Leucovorin (Arm C)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"83"},{"groupId":"FG002","numSubjects":"57"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"11"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"4"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"14"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"13"}],"type":"Clinical Deterioration"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Sponsor Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Started = Intent to Treat Population and includes all randomized participants","groupId":"FG000","numSubjects":"151"},{"groupId":"FG001","numSubjects":"149"},{"groupId":"FG002","numSubjects":"117"}],"type":"STARTED"},{"achievements":[{"comment":"Treated population: Patients who received at least 1 dose of study drug.","groupId":"FG000","numSubjects":"147"},{"groupId":"FG001","numSubjects":"134"},{"comment":"2 randomized Arm C patients did not receive study drug. 1 patient each in A and B received Arm C.","groupId":"FG002","numSubjects":"117"}],"type":"Treated Population"},{"achievements":[{"comment":"Completed = Subjects remaining on treatment at the time of the primary analysis data cut off.","groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"14"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"143"},{"groupId":"FG002","numSubjects":"103"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All patients were screened for UGT1A1\\*28 allele at baseline.","recruitmentDetails":"Patients were randomized over a period of 1.9 years starting from 2012-01-11 to 2013-09-11.\n\nThe study was initially a two-arm study with MM-398 monotherapy and 5-FU/LV control (protocol version 1) . A third arm of MM-398+5-FU/LV was added later (protocol version 2)."}