Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02254551
Status:
TERMINATED
Last Update Posted:
2017-02-16
First Post:
2014-09-29
Brief Title:
SafetyEfficacy Study of LDE225 Sonidegib Plus Bortezomib in Patients With Relapsed or RelapsedRefractory Multiple Myeloma
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
Phase II Trial of LDE225 Sonidegib Plus Bortezomib in Patients With Relapsed or RelapsedRefractory Multiple Myeloma With a Dose-Finding Lead-In
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety lead-in data did not support continuation of study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine whether the combination of LDE225 sonidegib plus bortezomib is safe and effective in the treatment of relapsed or relapsedrefractory multiple myeloma
Detailed Description:
Although multiple myeloma MM is considered fatal survival has dramatically improved with the introduction of more effective treatment options Despite these advances all patients eventually relapse and MM is generally considered incurable LDE225 Sonidegib is an oral investigational smoothened SMO inhibitor that has shown anti-tumor activity in certain cancers Bortezomib is a highly active drug for the treatment of MM and has produced response rates in relapsed andor refractory patients This study will investigate the tolerability and feasibility of combining LDE225 with bortezomib in patients with bortezomib-sensitive relapsed or relapsedrefractory MM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None