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
Completed · Phase 1
Conditions studied: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML
In brief
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.
Key facts
- Study ID
- NCT00964873
- Run by
- Synta Pharmaceuticals Corp.
- People needed
- 29
- Starts
- 2009-08-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2014-09-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Tampa, Florida, United States
- Study site — Baltimore, Maryland, United States
- Study site — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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