A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia
An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.
Arms and Interventions
|Experimental: 1 Part 1|
Drug: STA-9090 (ganetespib)
Primary Outcome Measures
- To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria [every 8 weeks]
Secondary Outcome Measures
- To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML [ongoing]
as per adverse event and serious adverse event reporting
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.
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.
Contacts and Locations
|3||Durham||North Carolina||United States||27710|
Sponsors and Collaborators
- Synta Pharmaceuticals Corp.
Study Documents (Full-Text)None provided.