Study of SX-682 Alone and in Combination with Oral or Intravenous Decitabine in Subjects with Myelodysplastic Syndrome

Eligibility Criteria

• * Diagnosis of MDS by World Health Organization criteria, and either
• 1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk patients without 5q deletion:
• 2. IPSS low risk or intermediate-1 risk patients with 5q deletion:
• 3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.
• * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• * Screening laboratory values:
• 1. Renal glomerular filtration rate (GFR) ≥ 30 ml/min;
• 2. Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;
• 3. Bilirubin \< 1.5 times upper limit of normal;
• 4. No history of HIV being HIV positive;
• 5. No active Hepatitis B or Hepatitis C infection.
• * Life expectancy ≥ 12 weeks.
• * Women of childbearing potential (WOCBP) must use study specified contraception.
• * WOCBP demonstrate negative pregnancy test.
• * Not breastfeeding.
• * Men sexually active must use study specified contraception.
• * Use of chemotherapeutic agents or experimental agents for MDS within 14 days of the first day of study drug treatment.
• * Use of erythroid stimulating agents, Granulocyte-colony stimulating factor (G-CSF), or Granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days of the first day of study drug treatment, or during the study.
• * Mean triplicate heart rate-corrected QT interval (QTc) \> 500 msec.
• * Any of the following cardiac abnormalities:
• 1. QT interval \> 480 msec corrected using Fridericia's formula;
• 2. Risk factors for Torsade de Pointes;
• 3. Use of medication that prolongs the QT interval with the exception of drugs that are considered absolutely essential for the care of the subject;
• 4. Myocardial infarction ≤ 6 months prior to first day of study drug treatment;
• 5. Unstable angina pectoris or serious uncontrolled cardiac arrhythmia.
• * Any serious or uncontrolled medical disorder.
• * Prior malignancy within the previous 2 years except for local cancers that have been cured; or patients who have been adequately treated and have low risk of reoccurrence.
• * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• * Use of other investigational drugs within 30 days of study drug administration.
• * Major surgery within 4 weeks of study drug administration.
• * Live-virus vaccination within 30 days of study drug administration.
• * Allergy to study drug component.