Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia

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. Identifier: NCT00360035
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : August 26, 2013
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )

Brief Summary:
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic 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.

Condition or disease Intervention/treatment Phase
Myelofibrosis Drug: Obatoclax mesylate (GX15-070MS) Phase 2

Detailed Description:
This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)
Study Start Date : July 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: GX15-070MS
Obatoclax mesylate 60mg
Drug: Obatoclax mesylate (GX15-070MS)
60 mg q2wks

Primary Outcome Measures :
  1. Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Peripheral blood counts [ Time Frame: 4 Weeks to 1 Year ]
  2. Bone marrow aspirates and biopsies [ Time Frame: 8 weeks to 1 year ]
  3. Transfusion and growth factor requirements [ Time Frame: 8 weeks to 1 year ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically confirmed myelofibrosis with myeloid metaplasia.
  • No limitations on allowable type and amount of prior therapy.
  • Patients must have normal organ function.
  • Must be willing to submit to blood sampling for planned PK and PD analyzes.
  • Must have ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

  • No other agents or therapies administered with the intent to treat malignancy.
  • Patients with prior exposure to obatoclax.
  • Uncontrolled, intercurrent illness.
  • Pregnant women and women who are breast feeding.

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 identifier (NCT number): NCT00360035

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Gemin X
Study Director: Jean Viallet, MD Gemin X, Inc.

Publications of Results:
Responsible Party: Gemin X Identifier: NCT00360035     History of Changes
Other Study ID Numbers: GEM007
First Posted: August 3, 2006    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes