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A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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.
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 patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
NW Georgia Oncology Centers
Marietta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Medical Center
Buffalo, New York, United States
University of Wisconsin
Madison, Wisconsin, United States
Start Date
October 1, 2006
Primary Completion Date
March 1, 2009
Completion Date
November 1, 2009
Last Updated
July 21, 2016
24
ACTUAL participants
Obatoclax mesylate
DRUG
Bortezomib
DRUG
Lead Sponsor
Gemin X
NCT03314974
NCT00877214
Data Source & Attribution
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