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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Mantle-Cell Lymphoma

Intervention / Treatment
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* Drug: Obatoclax mesylate
* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>30mg obatoclax, 1.0mg/m2 bortezomib | Drug: Obatoclax mesylate<br>* 30 mg, 45 mg<br>* Other names: (GX15-070MS);Drug: Bortezomib<br>* 1.0mg/m2, 1.3 mg/m2<br>|
| Experimental: 2<br>obatoclax 30 mg, bortezomib 1.3 mg/m2 | Drug: Obatoclax mesylate<br>* 30 mg, 45 mg<br>* Other names: (GX15-070MS);Drug: Bortezomib<br>* 1.0mg/m2, 1.3 mg/m2<br>|
| Experimental: 3<br>Obatoclax 45 mg, Bortezomib 1.3 mg/m2 | Drug: Obatoclax mesylate<br>* 30 mg, 45 mg<br>* Other names: (GX15-070MS);Drug: Bortezomib<br>* 1.0mg/m2, 1.3 mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile |  | 4 weeks to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements |  | 4 weeks to 2 years |