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Phase 1/Phase 2
17 Years
N/A
Not Enrolling
Both
Advanced MDS, Acute Myeloid Leukemia

Thank you

Trial Information

Inclusion Criteria


Key Inclusion Criteria (Part 2):

- Patients with either Intermediate-2 or High risk MDS or with AML (>20% bone marrow
blasts) with stable low or normal white blood cell count (WBC). Patients should have
failed one prior chemotherapy regimen which should have included a hypomethylating
agent.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.

- Discontinuation of prior treatment at least 2 weeks prior to the start of the study.

- Adequate hepatic and renal function.

- Additional criteria exist.

Key Exclusion Criteria (Part 2):

- Concurrent cytotoxic therapy, or biological, endocrine and immunological response
modifiers.

- Previous radiation to >25% of bone marrow.

- Other active malignancies.

- Known positive serology for the human immunodeficiency virus (HIV).

- Central nervous system involvement as documented by spinal fluid cytology.

- Active, uncontrolled infection.

- Additional criteria exist

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Establish the maximum tolerated dose (MTD) of the study drug.

Outcome Time Frame:

Part 1

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

ARRAY-520-211

NCT ID:

NCT00637052

Start Date:

February 2008

Completion Date:

June 2010

Related Keywords:

  • Advanced MDS
  • Acute Myeloid Leukemia
  • preleukemia
  • dysplasia of myeloid blood cells
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of Texas, M.D. Anderson Cancer Center Houston, Texas  77030
Emory University School of Medicine, Winship Cancer Center Atlanta, Georgia  30322