AML, CML, MDS, Myeloproliferative Disorders
Conditions
Keywords
Synta, STA-9090, AML, CML, MDS, myeloproliferative disorder, hematologic malignancy, ganetespib
Brief summary
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
Interventions
Chemotherapy agent
Sponsors
Synta Pharmaceuticals Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies | Feb 2011 |
| To assess preliminary evidence of anti-neoplastic activity | Feb 2011 |
| To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion | Feb 2011 |
Secondary
| Measure | Time frame |
|---|---|
| To assess changes in biomarkers following study drug administration | Feb 2011 |
| To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters | Feb 2011 |
| To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) | Feb 2011 |
Countries
United States
Outcome results
None listed