{"groups":[{"description":"Participants received Eribulin Mesylate 0.7 milligram per square meter (mg/m\\^2), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of disease progression (PD), unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.","id":"FG000","title":"Phase 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2"},{"description":"Participants received Eribulin Mesylate 1.0 mg/m\\^2, as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\\^2, as an intravenous infusion on Day 1 of a 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.","id":"FG001","title":"Phase 1b: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2"},{"description":"Participants received Eribulin Mesylate 1.0 mg/m\\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.","id":"FG002","title":"Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2"},{"description":"Participants received Gemcitabine 1000 mg/m\\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.","id":"FG003","title":"Phase 2: Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Phase 1b"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"7"}],"type":"Completed 1 Year Follow-Up Per Protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"6"}],"type":"Study Termination by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"22"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"42"},{"groupId":"FG003","numSubjects":"41"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"41"},{"groupId":"FG003","numSubjects":"39"}],"type":"Safety Analysis Set (SAS)/Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"40"},{"groupId":"FG003","numSubjects":"39"}],"type":"Modified-intent-to-treat (MITT)"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"42"},{"groupId":"FG003","numSubjects":"41"}],"type":"NOT COMPLETED"}],"title":"Phase 2"}],"preAssignmentDetails":"A total of 92 participants were enrolled in this study. This study consisted of two phases: Phase 1b and Phase 2. In Phase 1b, 9 participants were enrolled and received study treatment and in Phase 2, 83 participants were randomized, of which 80 participants received the study treatment.","recruitmentDetails":"Participants took part in the study at 32 investigative sites in Germany, Netherlands, Spain, Ukraine, United Kingdom and the United States from 16 April 2010 to 20 July 2016."}