Back to resultsSafety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Primary Purpose
Mantle-Cell Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Obatoclax mesylate
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Mantle-Cell Lymphoma
Eligibility 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
Sites / Locations
- NW Georgia Oncology Centers
- Northwestern University Feinberg School of Medicine
- Hackensack University Medical Center
- Roswell Park Medical Center
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
30mg obatoclax, 1.0mg/m2 bortezomib
obatoclax 30 mg, bortezomib 1.3 mg/m2
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
Outcomes
Primary Outcome Measures
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Secondary Outcome Measures
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00407303
Brief Title
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemin X
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
30mg obatoclax, 1.0mg/m2 bortezomib
Arm Title
2
Arm Type
Experimental
Arm Description
obatoclax 30 mg, bortezomib 1.3 mg/m2
Arm Title
3
Arm Type
Experimental
Arm Description
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
Intervention Type
Drug
Intervention Name(s)
Obatoclax mesylate
Other Intervention Name(s)
(GX15-070MS)
Intervention Description
30 mg, 45 mg
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
1.0mg/m2, 1.3 mg/m2
Primary Outcome Measure Information:
Title
Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile
Time Frame
4 weeks to 2 years
Secondary Outcome Measure Information:
Title
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements
Time Frame
4 weeks to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Viallet, MD
Organizational Affiliation
Gemin X, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
NW Georgia Oncology Centers
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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