Status:
COMPLETED
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
Lead Sponsor:
Gemin X
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00360035
Start Date
July 1 2006
End Date
February 1 2009
Last Update
August 26 2013
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
James A. Haley Veterans Hospital
Tampa, Florida, United States, 33612
3
Emory University
Atlanta, Georgia, United States, 30322
4
The University of Chicago
Chicago, Illinois, United States, 60637