Status:
COMPLETED
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
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00964873
Start Date
August 1 2009
End Date
August 1 2011
Last Update
September 18 2014
Active Locations (3)
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1
Tampa, Florida, United States, 33612
2
Baltimore, Maryland, United States, 21231
3
Durham, North Carolina, United States, 27710