Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies

Completed · Phase 1

Conditions studied: Hematological Malignancies

In brief

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 of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Key facts

Study ID

NCT00438178

Run by

Gemin X

People needed

44

Starts

2005-10-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No other agents or therapies administered for the intent to treat
• Uncontrolled, intercurrent illness
• Pregnant women and women who are breast feeding

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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