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

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.

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Key information

Conditions

Acute Myeloid Leukemia ALL AML Acute Lymphoblastic Leukemia Blast Crisis Blast-phase Chronic Myelogenous Leukemia Bone Marrow Diseases CML Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tampa, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STA-9090 (ganetespib)

Drug

Chemotherapy agent

Primary outcomes

To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria

Time frame: every 8 weeks

Secondary outcomes

To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML

Time frame: ongoing

as per adverse event and serious adverse event reporting

Sponsors and collaborators

Lead sponsor

Synta Pharmaceuticals Corp.

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Aug 25, 2009
Registry last updated: Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed