Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)

Completed · Phase 2

Conditions studied: Myelodysplastic Syndromes

In brief

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic 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. 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

Key facts

Study ID

NCT00413114

Run by

Gemin X

People needed

24

Starts

2006-12-01

Expected to finish

2009-11-01

Last updated by the study team

2013-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathological confirmation of Myelodysplastic Syndromes (MDS)
• 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

You may not qualify if…

• Must not be a result of prior chemotherapy and/or radiotherapy for another malignancy
• No other agents or therapies administered in the intent to treat
• Uncontrolled, intercurrent illness
• Pregnant women and women who are breast feeding

Where it is running

• 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

Full record on ClinicalTrials.gov

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