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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 CenterDurham, North Carolina  27710
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Kimmel Comprehensive Cancer Center at Johns Hopkins UniversityBaltimore, Maryland  21231