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
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Part 1
|
Drug: STA-9090 (ganetespib)
Chemotherapy agent
|
Outcome Measures
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
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ECOG Performance Status 0-2
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Adequate organ function as defined in the protocol.
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Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
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Hyperleukocytosis
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Acute Promyelocytic Leukemia (FAB-M3) subtype
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Uncontrolled Disseminated Intravascular Coagulation (DIC)
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Active central nervous system leukemia
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Concomitant radiation therapy, chemotherapy, or immunotherapy
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Women who are pregnant or lactating
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Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
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Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life
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Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these molecules
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Use of any investigational agents within two weeks or within six times the agent's half life --Treatment with chronic immunosuppressants
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Other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tampa | Florida | United States | 33612 | |
2 | Baltimore | Maryland | United States | 21231 | |
3 | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Synta Pharmaceuticals Corp.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9090-04