A Phase 1/2 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia - NCT00964873-27710 (Clinical Trial 385458)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy385458.aspx
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| City: |
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Durham |
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State:
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NC |
| Zip Code: |
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27710 |
| Conditions: |
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Acute Myeloid Leukemia - Acute Lymphoblastic Leukemia - Blast-phase Chronic Myelogenous Leukemia - AML - ALL - CML |
| Purpose: |
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An open-label phase 1/2 study to assess safety and efficacy of once-weekly STA-9090 in
subjects with AML, ALL and blast-phase CML.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase
CML
- ECOG Performance Status 0-2
- Adequate organ function as defined in the protocol.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Hyperleukocytosis
- Acute Promyelocytic Leukemia (FAB-M3) subtype
- Uncontrolled Disseminated Intravascular Coagulation (DIC)
- Active central nervous system leukemia
- Concomitant radiation therapy, chemotherapy, or immunotherapy
- Women who are pregnant or lactating
- Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
- Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or
within six times the agent's half life
- Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these
molecules
- Use of any investigational agents within two weeks or within six times the agent's
half life --Treatment with chronic immunosuppressants
- Other medical/psychiatric condition that may increase the risk associated with study
participation as defined by the protocol. |
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| Study is available at: |
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Duke University Medical Center
Durham, NC 27710
United States
Primary Contact:
Donna Adams, RN, MSN
Email: donna.adams@duke.edu
Phone: 919-668-4716
Secondary Contact:
Robert Bradley
Email: rbradley@syntapharma.com
Phone: 781-541-7985 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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