Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemin X
• Treatments: Bortezomib; Obatoclax

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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