ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00858572
Recruitment Status : Completed
First Posted : March 10, 2009
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

March 6, 2009
March 10, 2009
September 18, 2014
March 2009
May 2011   (Final data collection date for primary outcome measure)
  • To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies [ Time Frame: Feb 2011 ]
  • To assess preliminary evidence of anti-neoplastic activity [ Time Frame: Feb 2011 ]
  • To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion [ Time Frame: Feb 2011 ]
  • To characterize the safety and tolerability of STA-9090 in subjects with hematologic malignancies [ Time Frame: Feb 2011 ]
  • To assess preliminary evidence of anti-neoplastic activity [ Time Frame: Feb 2011 ]
  • To assess the pharmacokinetics of STA-9090 when administered as a short-term intravenous infusion [ Time Frame: Feb 2011 ]
Complete list of historical versions of study NCT00858572 on ClinicalTrials.gov Archive Site
  • To assess changes in biomarkers following study drug administration [ Time Frame: Feb 2011 ]
  • To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters [ Time Frame: Feb 2011 ]
  • To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) [ Time Frame: Feb 2011 ]
  • To assess changes in biomarkers following study drug administration [ Time Frame: Feb 2011 ]
  • To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters [ Time Frame: Feb 2011 ]
  • To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 [ Time Frame: Feb 2011 ]
Not Provided
Not Provided
 
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • AML
  • CML
  • MDS
  • Myeloproliferative Disorders
Drug: STA-9090 (ganetespib)
Chemotherapy agent
Experimental: Cohort
Intervention: Drug: STA-9090 (ganetespib)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
60
February 2013
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00858572
9090-03
No
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP