Last updated on September 2018

A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)


Brief description of study

Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine.

Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.

Clinical Study Identifier: NCT02632721

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Mayo Clinic Cancer Center
Jacksonville, FL United States
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Kommunalunternehmen Klinikum Augsburg
Augsburg, Germany
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Universit tsklinikum Carl Gustav Carus Dresden
Dresden, Germany
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Universit tsklinikum Jena
Jena, Germany
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Northwell Health
Lake Success, NY United States
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The Ohio State University Wexner Medical Center
Columbus, OH United States
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Hospital Vall d'Hebron
Barcelona, Spain
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Hospital Cl nic de Barcelona
Barcelona, Spain
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Hospital Polit cnic La Fe
Valencia, Spain
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A.O. Spedali Civili di Brescia
Brescia, Italy
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Vivantes Netzwerk f r Gesundheit GmbH
Berlin, Germany
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Emory University
Atlanta, GA United States
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Northwestern University
Chicago, IL United States
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Universit tsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Universit tsklinikum M nster
Münster, Germany
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