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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00407303
First received: December 1, 2006
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Mantle-Cell Lymphoma
Drug: Obatoclax mesylate (GX15-070MS)
Drug: Obatoclax
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile [ Time Frame: 4 weeks to 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements [ Time Frame: 4 weeks to 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: October 2006
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
30mg obatoclax, 1.0mg/m2 bortezomib
Drug: Obatoclax mesylate (GX15-070MS)
obatoclax at various doses in combination with bortezomib
Drug: Obatoclax
obatoclax in combo with bortezomib
Experimental: 2
obatoclax 30 mg, bortezomib 1.3 mg/m2
Drug: Obatoclax mesylate (GX15-070MS)
obatoclax at various doses in combination with bortezomib
Drug: Obatoclax
obatoclax in combo with bortezomib
Experimental: 3
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
Drug: Obatoclax mesylate (GX15-070MS)
obatoclax at various doses in combination with bortezomib
Drug: Obatoclax
obatoclax in combo with bortezomib

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407303

Locations
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
Investigators
Study Director: Jean Viallet, MD Gemin X, Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier: NCT00407303     History of Changes
Other Study ID Numbers: GEM012
Study First Received: December 1, 2006
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 19, 2014