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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964873
• Other study ID #: 9090-04
• Status: Completed
• Phase: Phase 1
• First received: August 24, 2009
• Last updated: September 17, 2014
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: September 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• ALL
• AML
• Blast Crisis
• Blast-phase Chronic Myelogenous Leukemia
• CML
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• STA-9090 (ganetespib)
Chemotherapy agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria		every 8 weeks	No
Secondary	To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML	as per adverse event and serious adverse event reporting	ongoing	Yes