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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00360035
First received: August 1, 2006
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Myelofibrosis
 Drug: Obatoclax mesylate (GX15-070MS)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peripheral blood counts [ Time Frame: 4 Weeks to 1 Year ] [ Designated as safety issue: Yes ]
  • Bone marrow aspirates and biopsies [ Time Frame: 8 weeks to 1 year ] [ Designated as safety issue: Yes ]
  • Transfusion and growth factor requirements [ Time Frame: 8 weeks to 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: July 2006
Study Completion Date: February 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GX15-070MS
Obatoclax mesylate 60mg
 Drug: Obatoclax mesylate (GX15-070MS)
60 mg q2wks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360035

Locations
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
Investigators
Study Director: Jean Viallet, MD Gemin X, Inc.
  More Information

Publications:

Responsible Party: Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier: NCT00360035     History of Changes
Other Study ID Numbers: GEM007
Study First Received: August 1, 2006
Last Updated: August 3, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 17, 2013