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Completed

NCT Number: NCT00858572

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

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

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Key information

Conditions

AML Bone Marrow Diseases CML Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases MDS Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STA-9090 (ganetespib)

Drug

Chemotherapy agent

Primary outcomes

  1. To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies

    Time frame: Feb 2011

  2. To assess preliminary evidence of anti-neoplastic activity

    Time frame: Feb 2011

  3. To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion

    Time frame: Feb 2011

Secondary outcomes

  1. To assess changes in biomarkers following study drug administration

    Time frame: Feb 2011

  2. To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters

    Time frame: Feb 2011

  3. To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)

    Time frame: Feb 2011

Sponsors and collaborators

Lead sponsor

Synta Pharmaceuticals Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Mar 10, 2009
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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