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

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT00858572

Collaborator

(none)

Enrollment

Locations

Arm

47.1

Duration (Months)

10.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AML CML MDS Myeloproliferative Disorders	Drug: STA-9090 (ganetespib)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort	Drug: STA-9090 (ganetespib) Chemotherapy agent

Arm

Intervention/Treatment

Experimental: Cohort

Drug: STA-9090 (ganetespib)

Chemotherapy agent

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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