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
18 Years
N/A
Both
Hematological Malignancies
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS
Principal Investigator
Jean Viallet, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gemin X, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
GX006
NCT ID:
NCT00438178
Start Date:
October 2005
Completion Date:
Related Keywords:
- Hematological Malignancies
- Neoplasms
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Myeloid
- Myelodysplastic Syndromes
- Hematologic Neoplasms
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Georgetown University Medical Center | Washington, District of Columbia 20007 |
