Study of FF-10501-01 in Patients With Relapsed or Refractory Hematological Malignancies

Inclusion Criteria: * Confirmed advanced hematologic malignancies; Phase 1: * High-risk MDS/CMML (defined as ≥ 10% peripheral blood or marrow blasts and/or IPSS score ≥ 1.5) and relapsed or refractory to prior therapy * AML relapsed or refractory to prior therapy, or ≥ 60 years of age and not a candidate for other therapies Phase 2a: * MDS/CMML, relapsed from, or refractory to, prior HMA therapy; the latter defined as failure to achieve clinical remission (CR), partial remission (PR) or hematologic improvement (HI) after previous HMA therapy (≥ 4 cycles of azacitidine or decitabine), or progression during, or toxicity to previous HMA therapy precluding further HMA treatment, and, * Bone marrow blast count ≥ 10% or peripheral blast count ≥ 5%, or IPSS-R score ≥ 3.5. * At least 3 weeks beyond the last chemotherapy, targeted anticancer agent, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1). Hydroxyurea used to control peripheral blast counts is permitted up to Day 7 of treatment on study. * Adequate performance status: ECOG ≤ 2; * Adequate renal and hepatic function: * creatinine ≤ 2.0 mg/dL, or calculated creatinine clearance ≥ 45 mL/min * total bilirubin ≤ 2 times the upper limit of normal (ULN) * ALT/AST ≤ 2 times ULN * Negative serum pregnancy test * Ability to provide written informed consent Exclusion Criteria: * Known history of coronary artery disease, angina, myocardial infarction, congestive heart failure, …