Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT02003573|
Recruitment Status : Terminated
First Posted : December 6, 2013
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Drug: decitabine iv Drug: volasertib iv infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 29, 2014|
|Actual Primary Completion Date :||January 6, 2015|
|Actual Study Completion Date :||May 15, 2016|
Experimental: volasertib + decitabine
dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))
Drug: decitabine iv
decitabine iv fixed dose
Drug: volasertib iv infusion
volasertib iv infusion (Body Surface Area (BSA) based dosing)
- Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1 [ Time Frame: 4 weeks ]
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.
- Number of Subjects With Dose Limiting Toxicities (DLT) in Cycle 1 [ Time Frame: 4 weeks ]Number of subjects with Dose Limiting Toxicities (DLT) in Cycle 1 is presented
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003573
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06510|
|United States, Missouri|
|Washington School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|