{"groups":[{"description":"Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"FG000","title":"Regorafenib (Stivarga, BAY73-4506)"},{"description":"Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.","id":"FG001","title":"Placebo First, Then Option of Open Label Regorafenib Treatment"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"3"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Non compliance with study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"receive no study drug"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"66"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"132"},{"groupId":"FG001","numSubjects":"66"}],"type":"Participants Received Treatment"},{"achievements":[{"comment":"91 participants started open-label treatment with regorafenib","groupId":"FG000","numSubjects":"91"},{"comment":"58 participants started open-label treatment with regorafenib","groupId":"FG001","numSubjects":"58"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"8"}],"type":"NOT COMPLETED"}],"title":"Double Blind Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"11"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"59"},{"groupId":"FG001","numSubjects":"32"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"transferred to rollover study"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Non-compliance with study drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Switching to other therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"58"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"91"},{"groupId":"FG001","numSubjects":"58"}],"type":"NOT COMPLETED"}],"title":"Open Label Treatment"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"7"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Not analyzed after cutoff 08Jun2015"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"No follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Progressive disease"}],"milestones":[{"achievements":[{"comment":"All participants who discontinued study drug entered 30-day Safety Follow-up","groupId":"FG000","numSubjects":"118"},{"comment":"All participants who discontinued study drug entered 30-day Safety Follow-up","groupId":"FG001","numSubjects":"52"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"37"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"15"}],"type":"NOT COMPLETED"}],"title":"Safety Follow-up"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"6"}],"type":"Not analyzed after cutoff 08Jun2015"}],"milestones":[{"achievements":[{"comment":"All participants entered Survival Follow-up immediately after safety follow-up","groupId":"FG000","numSubjects":"100"},{"comment":"All participants entered Survival Follow-up immediately after safety follow-up","groupId":"FG001","numSubjects":"39"}],"type":"STARTED"},{"achievements":[{"comment":"85 participants died and completed survival follow-up.","groupId":"FG000","numSubjects":"85"},{"comment":"33 participants died and completed survival follow-up.","groupId":"FG001","numSubjects":"33"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Survival Follow-up"}],"preAssignmentDetails":"Participants were randomized in a 2:1 ratio to receive either regorafenib (133 patients) or placebo (66 patients). Randomization was stratified according 3rd vs. 4th line of therapy (at least 50% of patients were to be 3rd line), and geographical region (Asia vs.rest of world).","recruitmentDetails":"A total of 240 participants with metastatic and/or unresectable GIST whose disease had progressed despite prior treatments with at least imatinib and sunitinib were screened; 199 were randomized. Patients must have shown objective disease progression or intolerance to imatinib, as well as disease progression while on sunitinib treatment."}