Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)
NCT ID: NCT00413114
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2006-12-31
2009-11-30
Brief Summary
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This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. 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 patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Obatoclax Mesylate
Obatoclax Mesylate 30mg
Obatoclax mesylate (GX15-070MS)
Interventions
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Obatoclax mesylate (GX15-070MS)
Eligibility Criteria
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Inclusion Criteria
* Patients must have had no prior systemic therapy
* Must have normal organ functions
* Must have the ability to understand and willingness to sign a written informed consent form
Exclusion Criteria
* No other agents or therapies administered in the intent to treat
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding
18 Years
ALL
No
Sponsors
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Gemin X
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Berger, MD
Role: STUDY_DIRECTOR
Gemin X, Inc.
Locations
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Stanford University
Stanford, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
James A. Haley Veterans Hospital
Tampa, Florida, United States
Emory University School of Medicine/ Winship Cancer Center
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Michigan State University, Breslin Cancer Center CTO
Lansing, Michigan, United States
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
Pacific Oncology
Portland, Oregon, United States
The West Clinic
Memphis, Tennessee, United States
Sarah Cannon Cancer Research Institute
Nashville, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers
Dallas, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
MD Anderson Cancer Center (Protocol 2006-0688)
Houston, Texas, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
QEII HSC
Halifax, Nova Scotia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hospital Notre-Dame du Chum
Montreal, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Countries
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References
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Arellano ML, Borthakur G, Berger M, Luer J, Raza A. A phase II, multicenter, open-label study of obatoclax mesylate in patients with previously untreated myelodysplastic syndromes with anemia or thrombocytopenia. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):534-9. doi: 10.1016/j.clml.2014.04.007. Epub 2014 Jun 12.
Other Identifiers
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GEM013
Identifier Type: -
Identifier Source: org_study_id