A Phase Ib/II Multicenter Open-label Study of BGB324 in Patients With AML or MDS
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|ClinicalTrials.gov Identifier: NCT02488408|
Recruitment Status : Unknown
Verified May 2017 by BerGenBio ASA.
Recruitment status was: Recruiting
First Posted : July 2, 2015
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndromes||Drug: BGB324 Drug: Cytarabine Drug: Decitabine||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Multicenter Open-label Study of BGB324 as a Single Agent and in Combination With Cytarabine or Decitabine in Patients With Acute Myeloid Leukemia or as a Single Agent in Patients With Myelodysplastic Syndrome|
|Actual Study Start Date :||September 2014|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Part A
To identify the maximum tolerated dose (MTD) of BGB324 in patients with relapsed or refractory AML following treatment with cytotoxic chemotherapy or a targeted or biologic agent, or in patients with high risk MDS (Norway only).
Experimental: Part B
To identify the safety and tolerability of BGB324:
Low dose cytarabine will be administered with BGB324 at a dose selected dose from Part A of the study
Other Name: Ara-C
Decitabine will be administered with BGB324 at a dose selected dose from Part A of the study
- Maximum tolerated dose (MTD) of BGB324 [ Time Frame: 15 Months ]Dose confirmation for Phase II
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): NCT02488408
|Contact: Murray Yale, MD, PhD||+44 7557 email@example.com|
|Contact: Sonja Loges, MD, PhD||+49 firstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Karen Parrott 319-353-6347 email@example.com|
|Principal Investigator: Carlos E Vigil, MD|
|United States, Ohio|
|James Cancer Hospital & Solove Research Institute||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Molly Vittorio 614-293-7940 firstname.lastname@example.org|
|Principal Investigator: William Blum, Professor|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Cora Cheung 713-792-3461 email@example.com|
|Principal Investigator: Jorge Cortes, Professor|
|Universitätsklinikum Frankfurt, Medizinische Klinik II||Recruiting|
|Frankfurt, Germany, 60596|
|Contact: Laura Hefermehl +49 69 6301 86708 Laura.Hefermehl@kgu.de|
|Principal Investigator: Jörg Chromik, Dr|
|University Medical Center Hamburg-Eppendorf Martinistrasse||Recruiting|
|Hamburg, Germany, 20246|
|Contact: Sonja T Loges, MD, PhD +49 407-410-51969 firstname.lastname@example.org|
|Principal Investigator: Sonja Loges, MD, PhD|
|Medizinische Hochschule Hannover||Recruiting|
|Hannover, Germany, 30625|
|Contact: Gabriele Samson +49 (511) 532 9321 email@example.com|
|Principal Investigator: Michael Heuser, Dr|
|Universitätsklinikum Ulm, Oberer Eselsberg, Zentrum für Innere Medizin III||Recruiting|
|Ulm, Germany, 89081|
|Contact: Manuela Wetzel +49 (0) 731 500 45709 firstname.lastname@example.org|
|Principal Investigator: Peter Paschka, Dr|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5021|
|Contact: Marianne Emblem Lehmann +47 59972890/ 95975516 email@example.com|
|Principal Investigator: Bjørn Tore Gjertsen, Professor|
|Principal Investigator:||Sonja Loges, MD, PhD||University Medical Center Hamburg-Eppendorf Martinistrasse|