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 currently recruiting participants.

Verified by Synta Pharmaceuticals Corp., December 2009

First Received: August 24, 2009 Last Updated: December 10, 2009 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 Blast-phase Chronic Myelogenous Leukemia AML ALL CML	Drug: STA-9090	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

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
1 Part 1/Part 2: Experimental	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

Contacts

Contact: Robert Bradley

781-541-7985

rbradley@syntapharma.com

Locations

United States, Florida
H. Lee Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Luz Diez, RN 813-745-4625 luz.diez@moffitt.org
Principal Investigator: Jeffrey E Lancet, MD
United States, Maryland
Kimmel Comprehensive Cancer Center at Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21231
Contact: Marianne Bytella, RN, BSN 410-614-6430 mbytell1@jhmi.edu
Principal Investigator: B. Douglas Smith, MD
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Donna Adams, RN, MSN 919-668-4716 donna.adams@duke.edu
Principal Investigator: David A Rizzieri, MD

Sponsors and Collaborators

Synta Pharmaceuticals Corp.

More Information

No publications provided

Responsible Party:	Synta Pharmaceuticals Corp. ( Robert Bradley )
Study ID Numbers:	9090-04
Study First Received:	August 24, 2009
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00964873 History of Changes
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, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Lymphatic Diseases
Leukemia
Neoplasms
Neoplastic Processes
Pathologic Processes
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Bone Marrow Diseases
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on February 04, 2010