Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase II Study of Obatoclax Mesylate (GX15-070MS) in Patients With Previously-Untreated Myelodysplastic Syndromes (MDS) With Anemia and/or Thrombocytopenia
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
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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