{"groups":[{"description":"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.\n\nBortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.\n\nExpansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.\n\nMaintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity.","id":"FG000","title":"LDE225 Plus Bortezomib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Dose-limiting toxicity"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"7"}],"type":"STARTED"},{"achievements":[{"comment":"1 patient was found to be refractory to bortezomib and deemed ineligible.","groupId":"FG000","numSubjects":"7"}],"type":"Cohort 1: LDE225 400mg"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"Cohort 2: LDE225 600mg"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"Cohort 3: LDE225 800mg"},{"achievements":[{"comment":"Due to toxicity and lack of efficacy, no other dose levels were examined.","groupId":"FG000","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Dose Escalation"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Expansion"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Maintenance"}],"preAssignmentDetails":"7 patients received at least 1 cycle (21 days) of treatment on dose level 1.","recruitmentDetails":"The primary objective of this study was to investigate safety, tolerability and determine the maximum tolerated dose (MTD) of LDE225 to administer along with a fixed dose of bortezomib. Between March 2015 and September 2015, 7 patients were enrolled in the safety lead-in part of the study at 4 investigational sites in the U.S."}