Dosing regimen

A method of treating AML in an elderly subject, wherein said subject:

• (I) has a white blood cell (WBC) count of less than about 10,000 cells/microliter and/or
• (II) has a cytogenetic risk classification according to the US Southwest Oncology Group (SWOG) that is not unfavourable, and/or
• (III) falls within a classification selected from antecedent myelodysplastic syndrome (MDS), antecedent myeloproliferative neoplasm (MPN), and antecedent myelodysplastic/myeloproliferative neoplasm (MDS/MPN);
• said method comprising administering to a subject a therapeutically effective amount of (i) sapacitabine;
• and (ii) decitabine;
• in accordance with a dosing regimen comprising at least one first treatment cycle and at least one second treatment cycle,
• wherein said first treatment cycle comprises administering decitabine intravenously in a dose of about 20 mg/m2per day for 5 to 10 consecutive days followed by a 3 to 5 week rest period, or until treatment-related toxicities are resolved, whichever is longer;
• and
• wherein said second treatment cycle comprises administering sapacitabine orally in a dose of about 300 mg b.i.d. for 3 consecutive days per week, for 2 weeks followed by a 2 to 4 week rest period, or until treatment-related toxicities are resolved, whichever is longer.

A kit of parts comprising:

• (i) sapacitabine, or a metabolite thereof;
• (ii) decitabine;
• and
• (iii) instructions for administering sapacitabine, or a metabolite thereof, and decitabine to a subject, in accordance with a dosing regimen comprising at least one first treatment cycle and at least one second treatment cycle, wherein said subject:
• (I) has a white blood cell (WBC) count of less than about 10,000 cells/microliter and/or
• (II) has a cytogenetic risk classification according to the US Southwest Oncology Group (SWOG) that is not unfavourable, and/or
• (III) falls within a classification selected from antecedent myelodysplastic syndrome (MDS), antecedent myeloproliferative neoplasm (MPN), and antecedent myelodysplastic/myeloproliferative neoplasm (MDS/MPN);
• wherein said first treatment cycle comprises administering a therapeutically effective amount of decitabine for 5 to 10 consecutive days followed by a rest period of from 3 to 5 weeks, or until treatment-related toxicities are resolved, whichever is longer;
• and
• wherein said second treatment cycle comprises administering a therapeutically effective amount of sapacitabine, or a metabolite thereof, for 3 consecutive days per week, for 2 weeks followed by a rest period of from 2 to 4 weeks, or until treatment-related toxicities are resolved, whichever is longer.