Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
Status:
Terminated
Trial end date:
2016-05-15
Target enrollment:
Participant gender:
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.