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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
60 mg q2wks
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
James A. Haley Veterans Hospital
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Time frame: 1 Year
Peripheral blood counts
Time frame: 4 Weeks to 1 Year
Bone marrow aspirates and biopsies
Time frame: 8 weeks to 1 year
Transfusion and growth factor requirements
Time frame: 8 weeks to 1 year
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University of Massachusetts Medical Center
Worcester, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Hospital
Toronto, Ontario, Canada