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
1 other identifier
interventional
31
1 country
3
Brief Summary
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2009
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 6, 2009
CompletedFirst Posted
Study publicly available on registry
March 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedSeptember 18, 2014
September 1, 2014
2.2 years
March 6, 2009
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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
Study Arms (1)
Cohort
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
New York, New York, 10065, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2009
First Posted
March 10, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2011
Study Completion
February 1, 2013
Last Updated
September 18, 2014
Record last verified: 2014-09