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

Phase 2

Completed

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: Obatoclax mesylate (GX15-070MS)

• Registration Number: NCT00413114
• Lead Sponsor: Gemin X

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Primary Completion: 2009-02
• Study Completion: 2009-11
• Status Verified: 2013-08
• Disposition First Submitted: 2013-08-16
• Disposition First Submitted QC: 2013-08-16
• Last Update Submitted: 2013-08-16
• Disposition First Posted: 2013-08-26
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obatoclax Mesylate	Obatoclax mesylate (GX15-070MS)	Obatoclax Mesylate 30mg

Primary Outcome Measures

Name	Time	Method
International Working Group (IWG) Response Criteria for MDS	52 weeks	Determine the response rate according to bone marrow blast count less than or equal to 10%

Secondary Outcome Measures

Name	Time	Method
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements	52 weeks	hemoglobin level less than 10 g/dL and or platelets less than 50 x 10 9/L. Eastern Cooperative Onocology Group (ECOG) performance status: 0 fully active-2 ambulatory 50% of the time; and total bilirubin less than or equal to 2 mg/dL; normal limits of SGOT/SGPT and creatinine according to laboratory standards

Trial Locations

Locations (22)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Michigan State University, Breslin Cancer Center CTO; 🇺🇸 Lansing, Michigan, United States

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Stanford University; 🇺🇸 Stanford, California, United States

The West Clinic; 🇺🇸 Memphis, Tennessee, United States

Northwest Georgia Oncology Centers; 🇺🇸 Marietta, Georgia, United States

Hematology-Oncology Centers of the Northern Rockies; 🇺🇸 Billings, Montana, United States

QEII HSC; 🇨🇦 Halifax, Nova Scotia, Canada

Arlington Cancer Center; 🇺🇸 Arlington, Texas, United States

Hospital Notre-Dame du Chum; 🇨🇦 Montreal, Quebec, Canada

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers; 🇺🇸 Dallas, Texas, United States

St. Vincent's Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

University of Massachusetts Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Mary Crowley Medical Research Center; 🇺🇸 Dallas, Texas, United States

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada

Emory University School of Medicine/ Winship Cancer Center; 🇺🇸 Atlanta, Georgia, United States

James A. Haley Veterans Hospital; 🇺🇸 Tampa, Florida, United States

Pacific Oncology; 🇺🇸 Portland, Oregon, United States

Sarah Cannon Cancer Research Institute; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center (Protocol 2006-0688); 🇺🇸 Houston, Texas, United States