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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00407303
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Mantle-Cell Lymphoma Drug: Obatoclax mesylate Drug: Bortezomib Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : October 2006
Primary Completion Date : March 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
30mg obatoclax, 1.0mg/m2 bortezomib
Drug: Obatoclax mesylate
30 mg, 45 mg
Other Name: (GX15-070MS)
Drug: Bortezomib
1.0mg/m2, 1.3 mg/m2
Experimental: 2
obatoclax 30 mg, bortezomib 1.3 mg/m2
Drug: Obatoclax mesylate
30 mg, 45 mg
Other Name: (GX15-070MS)
Drug: Bortezomib
1.0mg/m2, 1.3 mg/m2
Experimental: 3
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
Drug: Obatoclax mesylate
30 mg, 45 mg
Other Name: (GX15-070MS)
Drug: Bortezomib
1.0mg/m2, 1.3 mg/m2

Outcome Measures

Primary Outcome Measures :
  1. Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile [ Time Frame: 4 weeks to 2 years ]

Secondary Outcome Measures :
  1. Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements [ Time Frame: 4 weeks to 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407303

United States, Georgia
NW Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Medical Center
Buffalo, New York, United States, 14263
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Gemin X
Study Director: Jean Viallet, MD Gemin X, Inc.
More Information

Responsible Party: Gemin X
ClinicalTrials.gov Identifier: NCT00407303     History of Changes
Other Study ID Numbers: GEM012
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents