{"groups":[{"description":"Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.","id":"FG000","title":"Phase 1 Group A - Dose Finding"},{"description":"Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.","id":"FG001","title":"Phase 1 Group B - Dose Finding"},{"description":"Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.","id":"FG002","title":"Phase 1 Group C - Dose Finding"},{"description":"Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.","id":"FG003","title":"Phase 2 Group B"},{"description":"Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.","id":"FG004","title":"Phase 2 Group C"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Progressive Disease - pt withdrew"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"18"},{"groupId":"FG003","numSubjects":"38"},{"groupId":"FG004","numSubjects":"34"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"38"},{"groupId":"FG004","numSubjects":"34"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"12 patients were enrolled but not treated. Of these, 9 patients had events after enrollment that rendered them ineligible; 2 patients had progressive disease (PD); 1 patient withdrew consent. Since they were never dosed, these 12 patients were not included in efficacy or safety assessments.","recruitmentDetails":"Patients were enrolled between May 2007 and July 2010 across 16 study sites, all in the United States."}