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A Phase 1/2 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blastic Phase Chronic Myelogenous Leukemia, CML

Thank you

Trial Information

A Phase 1/2 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia


Inclusion Criteria:



- Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase
CML

- ECOG Performance Status 0-2

- Adequate organ function as defined in the protocol.

- Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

- Hyperleukocytosis

- Acute Promyelocytic Leukemia (FAB-M3) subtype

- Uncontrolled Disseminated Intravascular Coagulation (DIC)

- Active central nervous system leukemia

- Concomitant radiation therapy, chemotherapy, or immunotherapy

- Women who are pregnant or lactating

- Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment

- Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or
within six times the agent's half life

- Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these
molecules

- Use of any investigational agents within two weeks or within six times the agent's
half life --Treatment with chronic immunosuppressants

- Other medical/psychiatric condition that may increase the risk associated with study
participation as defined by the protocol.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

9090-04

NCT ID:

NCT00964873

Start Date:

August 2009

Completion Date:

December 2010

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • CML
  • Synta
  • STA-9090
  • Hematologic Cancers
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Blast-phase Chronic Myelogenous Leukemia
  • AML
  • ALL
  • CML
  • HSP90 Inhibitor
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Duke University Medical Center Durham, North Carolina  27710
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Kimmel Comprehensive Cancer Center at Johns Hopkins University Baltimore, Maryland  21231