Status:
COMPLETED
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
Lead Sponsor:
Gemin X
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition ...
Detailed Description
This is a multi-center, open-label, Phase I study of obatoclax administered every 2-week or weekly cycles, or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid Leukemia (AML), ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmation of AML, MDS, CML in blast phase, myelofibrosis, CLL, or aplastic anemia
- There are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade.
- Must have normal organ functions
- Must be willing to submit to blood sampling for the planned PK and PD analyses.
- Must have the ability to understand and willingness to sign a written informed consent form
Exclusion
- No other agents or therapies administered for the intent to treat
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00438178
Start Date
October 1 2005
Last Update
May 12 2014
Active Locations (3)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9