Leukemia, Myeloid, Acute Clinical Trial
Official title:
An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients >= 65 Years With Acute Myeloid Leukemia
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.
n/a
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