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

Phase 1

Completed

• Conditions: AML; MDS; Myeloproliferative Disorders; CML
• Interventions: Drug: STA-9090 (ganetespib)

• Registration Number: NCT00858572
• Lead Sponsor: Synta Pharmaceuticals Corp.

Brief Summary

The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-06
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2011-05
• Study Completion: 2013-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	STA-9090 (ganetespib)	-

Primary Outcome Measures

Name	Time	Method
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
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies	Feb 2011

Secondary Outcome Measures

Name	Time	Method
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
To assess changes in biomarkers following study drug administration	Feb 2011