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

Phase 1

Completed

• Conditions: CML; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; AML; ALL; Blast-phase Chronic Myelogenous Leukemia
• Interventions: Drug: STA-9090 (ganetespib)

• Registration Number: NCT00964873
• Lead Sponsor: Synta Pharmaceuticals Corp.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2010-12
• Study Completion: 2011-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 Part 1	STA-9090 (ganetespib)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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