Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia

• Status: Completed
• Trial end date: 2009-02-01
• 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 oncogenic 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gemin X
• Treatments: Obatoclax

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.