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411 : Phase I/II Study of Volasertib (BI 6727), an Intravenous Polo-Like Kinase (Plk) Inhibitor, in Patients with Acute Myeloid Leukemia (AML): Results From the Randomized Phase II Part for Volasertib in Combination with Low-Dose Cytarabine (LDAC) Versus LDAC Monotherapy in Patients with Previously Untreated AML Ineligible for Intensive Treatment

Researchers

Presenter

  • Michael Lubbert

Principal Investigators

  • Walter Fiedler

  • Alwin Kramer

  • Florian Voss

  • Co. KG

  • Tillmann Taube

  • Holger Fritsch

  • Hartmut Dohner

  • Loic Fouillard

  • Alf Haaland

  • Joseph M. Brandwein

  • Stephane Lepretre

  • Oumedaly Reman

  • Pascal Turlure

  • Gesine Bug

  • Carsten Muller-Tidow

Medical Centers

  • Biberach, Germany

  • Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, ON, Canada

  • Department of Hematology, Centre Hospitalier Universitaire Caen, Caen, France

  • Department of Hematology and Oncology, University Medical Center, Freiburg, Germany

  • Hubertus Wald Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

  • Department of Hematology, Centre Hospitalier de Meaux, Meaux Cedex, France,

  • Department of Hematologie Clinique et Therapie Cellulaire, Centre Hospitalo-Universitaire de Limoges, Limoges, France

  • Department of Internal Medicine V, University of Heidelberg and German Cancer Research Center DKFZ, Heidelberg, Germany

  • Department of Oncology, Oslo University Hospital, Oslo, Norway

  • Department of Medicine, Hematology/Oncology, Goethe University of Frankfurt, Frankfurt, Germany

  • Department of Hematology, University Hospital Leuven, Leuven, Belgium

  • Department of Hematology, Centre de Lutte Contre Le Cancer Henri Becquerel, Rouen, France

  • Ingelheim, Germany

Locations

  • Canada

  • Norway

  • Germany

  • France

  • Belgium

Companies

  • Boehringer Ingelheim

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Gastrointestinal syndrome

  • Acute myelocytic leukemia

  • Constipation

  • Neutropenia

  • Anemia

  • Solid malignancies

Biomarkers

  • Polo-like kinase 1

Drug/Treatment

  • Cytarabine liposomal

  • Volasertib

Outcome

  • N/A

Study Design

  • open label

  • randomized

  • drug-drug interaction

  • pharmacokinetics

Phase

  • NA

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • Interim

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