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

AML Clinical Trial

Official title:

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858572
• Other study ID #: 9090-03
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2009
• Last updated: September 17, 2014
• Start date: March 2009
• Est. completion date: February 2013

Study information

• Verified date: September 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• CML
• MDS
• Myeloproliferative Disorders

Intervention

Drug:
• STA-9090 (ganetespib)
Chemotherapy agent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

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