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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Synta Pharmaceuticals Corp..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00964873
First received: August 24, 2009
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  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 1
Phase 2

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:

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:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
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 June 17, 2013