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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00858572
First received: March 6, 2009
Last updated: September 17, 2014
Last verified: September 2014
  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

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 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies

Resource links provided by NLM:


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 ]

Enrollment: 31
Study Start Date: March 2009
Study Completion Date: February 2013
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858572

Locations
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.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00858572     History of Changes
Other Study ID Numbers: 9090-03
Study First Received: March 6, 2009
Last Updated: September 17, 2014
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:
Disease
Myeloproliferative Disorders
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014