A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia

This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus cytarabine induction chemotherapy for previously untreated patients with acute myeloid leukemia. (AML).

Main inclusion criteria: 1. AML, any subtype except acute promyelocytic leukemia (APL) 2. At least one of the following features: i. Age 18-75 with adverse risk cytogenetics ii. Age 18-75 with antecedent myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPD), or therapy-related AML iii. Age 60-75, regardless of risk category 3. No prior therapy for AML other than hydroxyurea 4. Judged by treating physician to be medically fit for induction chemotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 6. Normal left ventricular ejection fraction Subjects will receive induction chemotherapy consisting of idarubicin 12 mg/m2 on Days 1-3 plus cytarabine 200 mg/m2 (age 18-59) or 100 mg/m2 (age 60-75) as a continuous IV infusion x 7 days. Volasertib will be administered on day 4 in a dose-escalation schedule, using a standard 3+3 dose escalation design, over 3 dose levels. Once the MTD has been determined, an additional dose expansion cohort will be accrued.