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STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00858572
First received: March 6, 2009
Last updated: March 19, 2012
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.


Condition Intervention Phase
AML
CML
MDS
Myeloproliferative Disorders
 Drug: STA-9090 (ganetespib)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies [ Time Frame: Feb 2011 ] [ Designated as safety issue: Yes ]
  • To assess preliminary evidence of anti-neoplastic activity [ Time Frame: Feb 2011 ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion [ Time Frame: Feb 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess changes in biomarkers following study drug administration [ Time Frame: Feb 2011 ] [ Designated as safety issue: No ]
  • To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters [ Time Frame: Feb 2011 ] [ Designated as safety issue: Yes ]
  • To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) [ Time Frame: Feb 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: August 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort Drug: STA-9090 (ganetespib)
Chemotherapy agent

  Eligibility

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

Inclusion Criteria

  • Males and females 18 years or older
  • Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
  • Must have acceptable organ function during screening as defined in the protocol

Exclusion Criteria

  • Pregnant or breast-feeding women
  • Patients must meet the washout periods for prior chemotherapies and radiation
  • History of stroke within 6 months of treatment
  • Poor venous access for study drug administration
  • Treatment with chronic immunosuppressants
  • Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858572

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Robert Bradley/Clinical Trial Manager, Synta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00858572     History of Changes
Other Study ID Numbers: 9090-03
Study First Received: March 6, 2009
Last Updated: March 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
Synta
STA-9090
AML
CML
 MDS
myeloproliferative disorder
hematologic malignancy
ganetespib

Additional relevant MeSH terms:
Myeloproliferative Disorders
Hematologic Neoplasms
Bone Marrow Diseases
 Hematologic Diseases
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013