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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858572
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

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

Condition or disease Intervention/treatment Phase
AML CML MDS Myeloproliferative Disorders Drug: STA-9090 (ganetespib) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Cohort Drug: STA-9090 (ganetespib)
Chemotherapy agent

Primary Outcome Measures :
  1. To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies [ Time Frame: Feb 2011 ]
  2. To assess preliminary evidence of anti-neoplastic activity [ Time Frame: Feb 2011 ]
  3. To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion [ Time Frame: Feb 2011 ]

Secondary Outcome Measures :
  1. To assess changes in biomarkers following study drug administration [ Time Frame: Feb 2011 ]
  2. To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters [ Time Frame: Feb 2011 ]
  3. To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) [ Time Frame: Feb 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00858572

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United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New York
New York, New York, United States, 10065
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Synta Pharmaceuticals Corp.

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Responsible Party: Synta Pharmaceuticals Corp. Identifier: NCT00858572     History of Changes
Other Study ID Numbers: 9090-03
First Posted: March 10, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Synta Pharmaceuticals Corp.:
myeloproliferative disorder
hematologic malignancy

Additional relevant MeSH terms:
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Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases