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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:
ClinicalTrials.gov Identifier:
NCT00413114
First Posted: December 19, 2006
Last Update Posted: August 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndromes Drug: Obatoclax mesylate (GX15-070MS) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Gemin X ):

Primary Outcome Measures:
  • International Working Group (IWG) Response Criteria for MDS [ Time Frame: 52 weeks ]
    Determine the response rate according to bone marrow blast count less than or equal to 10%


Secondary Outcome Measures:
  • Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements [ Time Frame: 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


Enrollment: 24
Study Start Date: December 2006
Study Completion Date: November 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obatoclax Mesylate
Obatoclax Mesylate 30mg
Drug: Obatoclax mesylate (GX15-070MS)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413114


  Show 22 Study Locations
Sponsors and Collaborators
Gemin X
Investigators
Study Director: Mark Berger, MD Gemin X, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gemin X
ClinicalTrials.gov Identifier: NCT00413114     History of Changes
Other Study ID Numbers: GEM013
First Submitted: December 18, 2006
First Posted: December 19, 2006
Last Update Posted: August 26, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms