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

NCT ID: NCT00964873

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Part 1

Group Type: EXPERIMENTAL

STA-9090 (ganetespib)

Intervention Type: DRUG

Chemotherapy agent

Interventions

STA-9090 (ganetespib)

Chemotherapy agent

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tampa, Florida, United States

Baltimore, Maryland, United States

Durham, North Carolina, United States

Countries

United States

Other Identifiers

9090-04

Identifier Type: -

Identifier Source: org_study_id