AML Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | February 2013 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Synta Pharmaceuticals Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies | Feb 2011 | Yes | |
Primary | To assess preliminary evidence of anti-neoplastic activity | Feb 2011 | No | |
Primary | To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion | Feb 2011 | Yes | |
Secondary | To assess changes in biomarkers following study drug administration | Feb 2011 | No | |
Secondary | To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters | Feb 2011 | Yes | |
Secondary | To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) | Feb 2011 | No |
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