Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

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.

Timeline

Start

2014-01-29

Primary completion

2015-01-06

Completion

2016-05-15

Drugs

Indications