Back to resultsSTA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
Primary Purpose
AML, CML, MDS
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STA-9090 (ganetespib)
Sponsored by
About this trial
This is an interventional treatment trial for AML focused on measuring Synta, STA-9090, AML, CML, MDS, myeloproliferative disorder, hematologic malignancy, ganetespib
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cohort
Arm Description
Outcomes
Primary Outcome Measures
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
To assess preliminary evidence of anti-neoplastic activity
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
Secondary Outcome Measures
To assess changes in biomarkers following study drug administration
To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
Full Information
NCT ID
NCT00858572
First Posted
March 6, 2009
Last Updated
September 17, 2014
Sponsor
Synta Pharmaceuticals Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00858572
Brief Title
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
Official Title
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, CML, MDS, Myeloproliferative Disorders
Keywords
Synta, STA-9090, AML, CML, MDS, myeloproliferative disorder, hematologic malignancy, ganetespib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STA-9090 (ganetespib)
Intervention Description
Chemotherapy agent
Primary Outcome Measure Information:
Title
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
Time Frame
Feb 2011
Title
To assess preliminary evidence of anti-neoplastic activity
Time Frame
Feb 2011
Title
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
Time Frame
Feb 2011
Secondary Outcome Measure Information:
Title
To assess changes in biomarkers following study drug administration
Time Frame
Feb 2011
Title
To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
Time Frame
Feb 2011
Title
To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
Time Frame
Feb 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
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