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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-11-30

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.

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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.

Conditions

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Mantle-Cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

30mg obatoclax, 1.0mg/m2 bortezomib

Group Type EXPERIMENTAL

Obatoclax mesylate

Intervention Type DRUG

30 mg, 45 mg

Bortezomib

Intervention Type DRUG

1.0mg/m2, 1.3 mg/m2

2

obatoclax 30 mg, bortezomib 1.3 mg/m2

Group Type EXPERIMENTAL

Obatoclax mesylate

Intervention Type DRUG

30 mg, 45 mg

Bortezomib

Intervention Type DRUG

1.0mg/m2, 1.3 mg/m2

3

Obatoclax 45 mg, Bortezomib 1.3 mg/m2

Group Type EXPERIMENTAL

Obatoclax mesylate

Intervention Type DRUG

30 mg, 45 mg

Bortezomib

Intervention Type DRUG

1.0mg/m2, 1.3 mg/m2

Interventions

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Obatoclax mesylate

30 mg, 45 mg

Intervention Type DRUG

Bortezomib

1.0mg/m2, 1.3 mg/m2

Intervention Type DRUG

Other Intervention Names

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(GX15-070MS)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No