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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.

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.