Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients

Inclusion Criteria:

   - A histologically or pathologically confirmed diagnosis of AML based on WHO
   classification which is previously untreated by systemic therapy or is in first
   relapse after achieving a complete remission to initial induction, consolidation
   and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk
   risk which has been previously treated with hypomethylating agents

   - Age 70 years or older for AML and 60 years or older for MDS

   - Eastern Cooperative Oncology Group (ECOG) performance status 0-2

   - Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper
   limit of normal (ULN)

   - Adequate liver function defined as total bilirubin or direct bilirubin equal to or
   less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5
   x ULN (5 x ULN if tumor has affected the liver)

   - Life expectancy reasonably adequate for evaluating the treatment effect

   - Patient must be able to swallow capsules

   - Patients must be at least 2 weeks from prior systemic therapy, radiation therapy,
   major surgery, or other investigational therapy, and have recovered from clinically
   significant toxicities of these prior treatments

   - All men and women of reproductive potential must agree to practice effective
   contraception for 4 weeks prior to study entry, during the entire study period and for
   one month after the study unless documentation of infertility exists

   - Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

   - AML is of the sub-type of acute promyelocytic leukemia

   - Having received more than one induction systemic therapy for AML or having received a
   standard dose or high dose ara-C containing regimen for MDS

   - Patients with known central nervous system (CNS) involvement by leukemia

   - Uncontrolled intercurrent illness including, but not limited to ongoing or active
   infection, active cancer(s) other than AML, symptomatic congestive heart failure,
   unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
   that would limit compliance with study requirements. Patients receiving intravenous
   antibiotics for infections that are under control may be included in this study

   - Known to be HIV-positive