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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
AML, CML, MDS, Myeloproliferative Disorders

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Feb 2011

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

9090-03

NCT ID:

NCT00858572

Start Date:

March 2009

Completion Date:

August 2012

Related Keywords:

  • AML
  • CML
  • MDS
  • Myeloproliferative Disorders
  • Synta
  • STA-9090
  • AML
  • CML
  • MDS
  • myeloproliferative disorder
  • hematologic malignancy
  • ganetespib
  • Myeloproliferative Disorders
  • Hematologic Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development San Antonio, Texas  78229