Back to resultsSafety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
Primary Purpose
Myelofibrosis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Obatoclax mesylate (GX15-070MS)
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis
Eligibility Criteria
Inclusion Criteria: Histologically confirmed myelofibrosis with myeloid metaplasia. No limitations on allowable type and amount of prior therapy. Patients must have normal organ function. Must be willing to submit to blood sampling for planned PK and PD analyzes. Must have 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
- Georgetown University Medical Center
- James A. Haley Veterans Hospital
- Emory University
- The University of Chicago
- University of Massachusetts Medical Center
- MD Anderson Cancer Center
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GX15-070MS
Arm Description
Obatoclax mesylate 60mg
Outcomes
Primary Outcome Measures
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
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
NCT00360035
Brief Title
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
Official Title
A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
February 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 II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GX15-070MS
Arm Type
Experimental
Arm Description
Obatoclax mesylate 60mg
Intervention Type
Drug
Intervention Name(s)
Obatoclax mesylate (GX15-070MS)
Intervention Description
60 mg q2wks
Primary Outcome Measure Information:
Title
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Peripheral blood counts
Time Frame
4 Weeks to 1 Year
Title
Bone marrow aspirates and biopsies
Time Frame
8 weeks to 1 year
Title
Transfusion and growth factor requirements
Time Frame
8 weeks to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed myelofibrosis with myeloid metaplasia.
No limitations on allowable type and amount of prior therapy.
Patients must have normal organ function.
Must be willing to submit to blood sampling for planned PK and PD analyzes.
Must have 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
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
James A. Haley Veterans Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20709666
Citation
Parikh SA, Kantarjian H, Schimmer A, Walsh W, Asatiani E, El-Shami K, Winton E, Verstovsek S. Phase II study of obatoclax mesylate (GX15-070), a small-molecule BCL-2 family antagonist, for patients with myelofibrosis. Clin Lymphoma Myeloma Leuk. 2010 Aug;10(4):285-9. doi: 10.3816/CLML.2010.n.059.
Results Reference
result
Learn more about this trial
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
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