Status:
COMPLETED
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Lead Sponsor:
Gemin X
Conditions:
Mantle-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- Pathological confirmation of Mantle Cell Lymphoma (ML)
- Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
- Must have normal organ function
- Must have the ability to understand and willingness to sign a written informed consent form
Exclusion
- No other agents or therapies administered with the intent to treat malignancy
- Patients with prior exposure to obatoclax
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00407303
Start Date
October 1 2006
End Date
November 1 2009
Last Update
July 21 2016
Active Locations (5)
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1
NW Georgia Oncology Centers
Marietta, Georgia, United States, 30060
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Roswell Park Medical Center
Buffalo, New York, United States, 14263