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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)



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City:  Durham
State:  
NC
Zip Code: 27710
Conditions: Acute Myeloid Leukemia - Acute Lymphoblastic Leukemia - Blast-phase Chronic Myelogenous Leukemia - AML - ALL - CML
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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