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:
Gemin X
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00407303
First received: December 1, 2006
Last updated: July 25, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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: | July 25, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013