A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes

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) of 0, 1 or 2.
• Adequate liver and renal function.
• Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

• History of bone marrow transplant.
• Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
• 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 prolonged side effects.
• Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
• Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
• Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
• Additional criteria exist.