Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)for the Treatment of Myelodysplastic Syndromes (MDS)

Summary

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic 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. This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed

Timeline

Start

2006-12

Primary completion

2009-02

Completion

2009-11

Publications

• Arellano ML, Borthakur G, Berger M, Luer J, Raza A. A phase II, multicenter, open-label study of obatoclax mesylate in patients with previously untreated myelodysplastic syndromes with anemia or thrombocytopenia. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):534-9. doi: 10.1016/j.clml.2014.04.007. Epub 2014 Jun 12.

Drugs

Indications