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

Sponsored by:	Gemin X
Information provided by:	Gemin X
ClinicalTrials.gov Identifier:	NCT00407303

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 I Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Gemin X:

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 ]

Estimated Enrollment:	60
Study Start Date:	October 2006
Estimated Study Completion Date:	November 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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
3: Experimental 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
4: Experimental Obatoclax 45 mg over 24 hours, 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
5: Experimental Obatoclax 60 mg over 24 hours, 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

Contacts

Contact: Tara Porrey	610-640-5735 ext 23	tporrey@geminx.com
Contact: Calista Gauthier	610-640-5735 ext 19	cgauthier@geminx.com

Locations

United States, California
	Not yet recruiting
Los Angeles, California, United States
United States, Florida
	Not yet recruiting
Miami, Florida, United States
United States, Georgia
	Not yet recruiting
Marietta, Georgia, United States
United States, New Jersey
	Recruiting
Hackensack, New Jersey, United States
United States, New York
	Not yet recruiting
Buffalo, New York, United States
United States, Wisconsin
	Not yet recruiting
Madison, Wisconsin, United States

Sponsors and Collaborators

Gemin X

Investigators

Study Director:

Jean Viallet, MD

Gemin X, Inc.

More Information

Responsible Party:	Gemin X, Inc. ( Mark Berger, MD / VP Clinical Operations )
Study ID Numbers:	GEM012
Study First Received:	December 1, 2006
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00407303
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Bortezomib

Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Mantle cell lymphoma
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009