Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- Registration Number
- NCT00407303
- Lead Sponsor
- Gemin X
- 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 patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Obatoclax mesylate 30mg obatoclax, 1.0mg/m2 bortezomib 2 Obatoclax mesylate obatoclax 30 mg, bortezomib 1.3 mg/m2 3 Obatoclax mesylate Obatoclax 45 mg, Bortezomib 1.3 mg/m2 1 Bortezomib 30mg obatoclax, 1.0mg/m2 bortezomib 3 Bortezomib Obatoclax 45 mg, Bortezomib 1.3 mg/m2 2 Bortezomib obatoclax 30 mg, bortezomib 1.3 mg/m2
- Primary Outcome Measures
Name Time Method Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile 4 weeks to 2 years
- Secondary Outcome Measures
Name Time Method Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements 4 weeks to 2 years
Trial Locations
- Locations (5)
Roswell Park Medical Center
🇺🇸Buffalo, New York, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
NW Georgia Oncology Centers
🇺🇸Marietta, Georgia, United States