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

Mantle-Cell Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407303
• Other study ID #: GEM012
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 1, 2006
• Last updated: July 19, 2016
• Start date: October 2006
• Est. completion date: November 2009

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle-Cell Lymphoma

Intervention

Drug:
• Obatoclax mesylate
30 mg, 45 mg
• Bortezomib
1.0mg/m2, 1.3 mg/m2

Locations

Country	Name	City	State
United States	Roswell Park Medical Center	Buffalo	New York
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of Wisconsin	Madison	Wisconsin
United States	NW Georgia Oncology Centers	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile		4 weeks to 2 years	Yes
Secondary	Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements		4 weeks to 2 years	Yes