Hematological Malignancies Clinical Trial
Official title:
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
NCT number | NCT00438178 |
Other study ID # | GX006 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | February 21, 2007 |
Last updated | May 9, 2014 |
Start date | October 2005 |
Verified date | May 2014 |
Source | Teva Pharmaceutical Industries |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Georgetown University Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Gemin X |
United States, Canada,
Schimmer AD, O'Brien S, Kantarjian H, Brandwein J, Cheson BD, Minden MD, Yee K, Ravandi F, Giles F, Schuh A, Gupta V, Andreeff M, Koller C, Chang H, Kamel-Reid S, Berger M, Viallet J, Borthakur G. A phase I study of the pan bcl-2 family inhibitor obatocla — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the recommended Phase II dose of GX15-070MS; Characterize the DLTs of GX15-070MS; Determine the PK/PD response to GX15-070MS | |||
Secondary | Describe any clinical responses of patient with hematological malignancies. |
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