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

Myelodysplastic Syndromes Clinical Trial

Official title:

A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413114
• Other study ID #: GEM013
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2006
• Last updated: August 16, 2013
• Start date: December 2006
• Est. completion date: November 2009

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Obatoclax mesylate (GX15-070MS)

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	QEII HSC	Halifax	Nova Scotia
Canada	Hospital Notre-Dame du Chum	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Arlington Cancer Center	Arlington	Texas
United States	Emory University School of Medicine/ Winship Cancer Center	Atlanta	Georgia
United States	Hematology-Oncology Centers of the Northern Rockies	Billings	Montana
United States	University of Chicago	Chicago	Illinois
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers	Dallas	Texas
United States	MD Anderson Cancer Center (Protocol 2006-0688)	Houston	Texas
United States	Michigan State University, Breslin Cancer Center CTO	Lansing	Michigan
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	The West Clinic	Memphis	Tennessee
United States	Sarah Cannon Cancer Research Institute	Nashville	Tennessee
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	Pacific Oncology	Portland	Oregon
United States	Stanford University	Stanford	California
United States	James A. Haley Veterans Hospital	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements	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	52 weeks	No