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

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964873

Enrollment

Registered

2009-08-25

Start date

2009-08-31

Completion date

2011-08-31

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, ALL, AML, Blast-phase Chronic Myelogenous Leukemia, CML

Keywords

Synta, STA-9090, ganetespib, Hematologic Cancers, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML, HSP90 Inhibitor

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.

Interventions

DRUGSTA-9090 (ganetespib)

Chemotherapy agent

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria	every 8 weeks

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026