Know Cancer

or
forgot password


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

Thank you

Trial Information

Inclusion Criteria


Key Inclusion Criteria (Part 1 and Part 2):

- Diagnosis of MDS by bone marrow biopsy.

- International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk
MDS.

- May have received prior therapy for MDS.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.

- Adequate liver and renal function.

- Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

- History of bone marrow transplant.

- Concomitant malignancies or previous malignancies with less than a 2-year
disease-free interval at the time of enrollment.

- Treatment with an investigational medicinal product that is not expected to be
cleared by the first dose of study drug or that has demonstrated to have late side
effects.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C
and/or active hepatitis B.

- Additional criteria exist.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.

Outcome Time Frame:

Part 1, one year; Part 2, one year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

ARRAY-614-111

NCT ID:

NCT00916227

Start Date:

June 2009

Completion Date:

December 2013

Related Keywords:

  • Myelodysplastic Syndromes
  • Low or Intermediate-1 Risk Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Winship Cancer InstituteAtlanta, Georgia  30322
Moffitt Cancer CenterTampa, Florida  33612