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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00413114
First received: December 18, 2006
Last updated: August 16, 2013
Last verified: August 2013

December 18, 2006
August 16, 2013
December 2006
February 2009   (final data collection date for primary outcome measure)
International Working Group (IWG) Response Criteria for MDS [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Determine the response rate according to bone marrow blast count less than or equal to 10%
Determine the response rate to obatoclax and characterize the safety profile.
Complete list of historical versions of study NCT00413114 on ClinicalTrials.gov Archive Site
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
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
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: Obatoclax mesylate (GX15-070MS)
Experimental: Obatoclax Mesylate
Obatoclax Mesylate 30mg
Intervention: Drug: Obatoclax mesylate (GX15-070MS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00413114
GEM013
No
Teva Pharmaceutical Industries ( Gemin X )
Gemin X
Not Provided
Study Director: Mark Berger, MD Gemin X, Inc.
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP