Conditions: Leukemia, Myeloid, Acute
Allocation:  | Intervention model: SEQUENTIAL
Enrollment: 13
Healthy volunteers: no

Brief summary:
Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status.

MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.

Detailed description:

Arms:
arm 1: dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))

Interventions: intervention 1: decitabine iv intervention 2: volasertib iv infusion
Intervention descriptions: intervention 1: decitabine iv fixed dose intervention 2: volasertib iv infusion (Body Surface Area (BSA) based dosing)

Protocol document: