Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)
A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia
1 other identifier
interventional
24
2 countries
22
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2006
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 18, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedAugust 26, 2013
August 1, 2013
2.2 years
December 18, 2006
August 16, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
International Working Group (IWG) Response Criteria for MDS
Determine the response rate according to bone marrow blast count less than or equal to 10%
52 weeks
Secondary Outcomes (1)
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
52 weeks
Study Arms (1)
Obatoclax Mesylate
EXPERIMENTALObatoclax Mesylate 30mg
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gemin Xlead
Study Sites (22)
Stanford University
Stanford, California, 00000, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
James A. Haley Veterans Hospital
Tampa, Florida, 33612, United States
Emory University School of Medicine/ Winship Cancer Center
Atlanta, Georgia, 30322, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01605, United States
Michigan State University, Breslin Cancer Center CTO
Lansing, Michigan, 48910, United States
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, 59101, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 01605, United States
Pacific Oncology
Portland, Oregon, 97210, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Sarah Cannon Cancer Research Institute
Nashville, Tennessee, 37203, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers
Dallas, Texas, 75231, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center (Protocol 2006-0688)
Houston, Texas, 77030, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
QEII HSC
Halifax, Nova Scotia, B3H 2Y9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hospital Notre-Dame du Chum
Montreal, Quebec, H2L4M1, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Related Publications (1)
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.
PMID: 25052051DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Berger, MD
Gemin X, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2006
First Posted
December 19, 2006
Study Start
December 1, 2006
Primary Completion
February 1, 2009
Study Completion
November 1, 2009
Last Updated
August 26, 2013
Record last verified: 2013-08