NCT00413114

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

A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Gemin X · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Obatoclax mesylate (GX15-070MS)

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-02-01
• Completion: 2009-11-01
• First posted: 2006-12-19
• Last updated: 2013-08-26

Locations

22 sites across 2 countries: United States, Canada