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

Gemin X

Status and phase: Completed; Phase 2; Phase 1

Conditions: Mantle-Cell Lymphoma

Treatments: Drug: Bortezomib; Drug: Obatoclax mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407303

GEM012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

1

Experimental group

Description:

30mg obatoclax, 1.0mg/m2 bortezomib

Treatment:

Drug: Obatoclax mesylate

Drug: Bortezomib

2

Experimental group

Description:

obatoclax 30 mg, bortezomib 1.3 mg/m2

Treatment:

Drug: Obatoclax mesylate

Drug: Bortezomib

3

Experimental group

Description:

Obatoclax 45 mg, Bortezomib 1.3 mg/m2

Treatment:

Drug: Obatoclax mesylate

Drug: Bortezomib