Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes
Both
Myelodysplastic Syndromes
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 Center | Houston, Texas 77030-4096 |
| Winship Cancer Institute | Atlanta, Georgia 30322 |
| Moffitt Cancer Center | Tampa, Florida 33612 |
