A Phase I Study of Obatoclax Mesylate (GX15-070MS) in 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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS
Jean Viallet, MD
Study Director
Gemin X, Inc.
United States: Food and Drug Administration
GX006
NCT00438178
October 2005
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Georgetown University Medical Center | Washington, District of Columbia 20007 |