Status:
COMPLETED
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Hodgkin's Lymphoma
Lead Sponsor:
Gemin X
Conditions:
Hodgkin's Lymphoma
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 ...
Eligibility Criteria
Inclusion
- Pathological confirmation of Hodgkin's Lymphoma.
- Must have measurable disease.
- Evidence of progressive disease following at least one prior line of combination therapy.
- Must have failed, refused, or otherwise not a candidate for stem cell transplant.
- Patient's must have normal organ function.
- Willing to submit to blood sampling for planned PK and PD analyses.
- 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.
- Prior allogeneic stem cell transplant if evidence of graft versus host disease, or requirement for steroids or other immunosuppressive therapy.
- 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 :
November 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00359892
Start Date
July 1 2006
End Date
November 1 2008
Last Update
August 6 2012
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030