NCT00407303

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

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Gemin X · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mantle-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Obatoclax mesylate	30 mg, 45 mg
DRUG	Bortezomib	1.0mg/m2, 1.3 mg/m2

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-03-01
• Completion: 2009-11-01
• First posted: 2006-12-05
• Last updated: 2016-07-21

Locations

5 sites across 1 country: United States