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

September 17, 2014 updated by: Synta Pharmaceuticals Corp.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • New York
      • New York, New York, United States, 10065
    • Texas
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
Time Frame: Feb 2011
Feb 2011
To assess preliminary evidence of anti-neoplastic activity
Time Frame: Feb 2011
Feb 2011
To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
Time Frame: Feb 2011
Feb 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess changes in biomarkers following study drug administration
Time Frame: Feb 2011
Feb 2011
To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
Time Frame: Feb 2011
Feb 2011
To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
Time Frame: Feb 2011
Feb 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9090-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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