A Phase 1/2 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

First Received on August 24, 2009. Last Updated on January 20, 2011 History of Changes

Sponsor:	Synta Pharmaceuticals Corp.
Information provided by:	Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT00964873

Purpose

An open-label phase 1/2 study to assess safety and efficacy of once-weekly STA-9090 in subjects with AML, ALL and blast-phase CML.

Condition	Intervention	Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Blastic Phase Chronic Myelogenous Leukemia CML	Drug: STA-9090	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1/2 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

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Leukemia

U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:

To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

To characterize the safety and tolerability of once-weekly STA-9090 in subjects with AML, ALL and blast-phase CML [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Part 1/Part 2	Drug: STA-9090 Chemotherapy agent

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964873

Locations

United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Maryland
Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Synta Pharmaceuticals Corp.

More Information

No publications provided

Responsible Party:	Robert Bradley, Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT00964873 History of Changes
Other Study ID Numbers:	9090-04
Study First Received:	August 24, 2009
Last Updated:	January 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:

Synta
STA-9090
Hematologic Cancers
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

Blast-phase Chronic Myelogenous Leukemia
AML
ALL
CML
HSP90 Inhibitor

Additional relevant MeSH terms:

Blast Crisis
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic

Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012