A Phase I, Two-part Study to Determine the Recommended Dose and Evaluate the Safety and Tolerability of a Novel Oral Arsenic Trioxide Formulation (ORH-2014) in Subjects With Advanced Hematological Disorders

Exclusion Criteria

• •Eastern Cooperative Oncology Group performance status of ≥3;
• •Absolute myeloblast count ≥20,000/mm\^3;
• •Administration of any antineoplastic therapy within 5 half-lives of the antineoplastic therapy before the first dose of ORH-2014, with the exception of hydroxyurea that should be discontinued 1 day prior to the first dose of ORH-2014
• •Presence of any remaining toxicities due to previous chemotherapy
• •Participation in other clinical trials within at least 2 weeks of the first ORH-2014 dose;
• •Clinical evidence of active central nervous system leukemia;
• •Active and uncontrolled infection
• •Major surgery within 2 weeks prior to trial entry;
• •Liver function tests above the following limits at Screening: total bilirubin \>1.5 x upper limit of normal (ULN) unless related to Gilbert's syndrome or hemolysis; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x ULN; for subjects with liver involvement, AST and/or ALT \>5 x ULN;
• •Serum creatinine \>1.5 x ULN and/or creatinine clearance or estimated glomerular filtration rate \<30 mL/min
• •Impaired cardiac function
• •Myocardial infarction of unstable angina within 6 months prior to the planned start date of study drug.