Last updated on February 2018

A Phase Ib/II Multicenter Open-label Study of BGB324 in Patients With AML or MDS

Brief description of study

A Phase Ib/II multicentre open label study of BGb324 as a single agent in patients with AML or MDS or in a combination with cytarabine and decitabine in AML patients.

BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor which is overexpressed in up to half of AML cases.

Detailed Study Description

This study is a dose-escalation of BGB324, an Axl kinase inhibitor, in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), followed by a cohort expansion study of BGB324 either as a single agent in patients with AML or MDS, or in combination with cytarabine (cytosine arabinoside, Ara-C) or decitabine in patients with AML.

The study will run in Germany, Norway and the US and may enrol up to approximately 75 patients with AML or MDS.

The study consists of a dose-escalation phase to determine the MTD and/or recommended dose for Phase II (RP2D) of BGB324 in patients with relapsed or refractory AML or MDS (Part A) followed by a cohort expansion phase in up to four disease-specific cohorts (Part B).

BGB324 will be administered orally according to a daily schedule, with the first three doses of Cycle 1 serving as a 'loading' dose. Each 21-day (three week) period will constitute 1 cycle of treatment.

Clinical Study Identifier: NCT02488408

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Carlos E Vigil, MD

University of Iowa Hospitals and Clinics
Iowa City, IA United States
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William Blum, Professor

James Cancer Hospital & Solove Research Institute
Columbus, OH United States
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Jorge Cortes, Professor

MD Anderson Cancer Center
Houston, TX United States
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Jörg Chromik, Dr

Universit tsklinikum Frankfurt, Medizinische Klinik II
Frankfurt, Germany
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Sonja Loges, MD, PhD

University Medical Center Hamburg-Eppendorf Martinistrasse
Hamburg, Germany
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Michael Heuser, Dr

Medizinische Hochschule Hannover
Hannover, Germany
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Peter Paschka, Dr

Universit tsklinikum Ulm, Oberer Eselsberg, Zentrum f r Innere Medizin III
Ulm, Germany
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Bjørn Tore Gjertsen, Professor

Haukeland University Hospital
Bergen, Norway
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Recruitment Status: Open

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