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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
13
decitabine iv fixed dose
volasertib iv infusion (Body Surface Area (BSA) based dosing)
Yale Cancer Center
New Haven, Connecticut, United States
Washington School of Medicine
St Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with decitabine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and decitabine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1.
Time frame: 4 weeks
Number of Subjects With Dose Limiting Toxicities (DLT) in Cycle 1
Number of subjects with Dose Limiting Toxicities (DLT) in Cycle 1 is presented
Time frame: 4 weeks
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