Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407303
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2006-12-01
Brief Title:
Safety and Efficacy of Obatoclax Mesylate GX15-070MS in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma MCL
Sponsor:
Gemin X
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Phase III Study of Obatoclax Mesylate GX15-070MS Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma MCL
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins thereby reinstating the natural process of cell death that is often inhibited in cancer cells
Detailed Description:
This is a multi-center open-label Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma Treatment may be administered on an outpatient basis No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patientss malignancy Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed
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