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

Synta Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

AML

Blast-phase Chronic Myelogenous Leukemia

CML

ALL

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Treatments

Drug: STA-9090 (ganetespib)

Study type

Interventional

Funder types

Industry

Identifiers

9090-04

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.