Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies
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.
This is a multi-center, open-label, Phase I study of obatoclax administered every 2-week or
 weekly cycles, or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid
 Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid
 Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or
 Aplastic Anemia. Due to the PK/PD sampling schedule Cycle 1 will require overnight
 hospitalization. For the following cycles treatment may be administered on an outpatient
 basis but is at the discretion of the investigator. No investigational or commercial agents
 or therapies other than those described within the protocol may be administered with the
 intent to treat the patient's malignancy. Supportive care measures including those directed
 at controlling symptoms resulting from hematological malignancies are allowed.
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