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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemin X
• Treatments: Obatoclax

Criteria

Inclusion Criteria:

• 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 Criteria:

• No other agents or therapies administered for the intent to treat

• Uncontrolled, intercurrent illness

• Pregnant women and women who are breast feeding