{"classes":[{"categories":[{"measurements":[{"comment":"The MTD was not reached. Due to lack of efficacy and toxicity seen during dose level 1, additional dose levels were not examined and the study was terminated.","groupId":"OG000","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"}],"units":"Participants"}],"description":"During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.","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":"OG000","title":"LDE225 Plus Bortezomib"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"every 3 weeks up to 48 weeks","title":"Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib","type":"PRIMARY"}