70
Participants
Start Date
October 10, 2018
Primary Completion Date
August 31, 2021
Study Completion Date
August 31, 2022
DKN-01 300 mg
DKN-01 will be administered intravenous (IV) over a minimum of 30 minutes and up to a maximum of 2 hours given on days 1 and 15 of each 28 day cycle.
DKN-01 600 mg
DKN-01 will be administered intravenous (IV) over a minimum of 30 minutes and up to a maximum of 2 hours given on days 1 and 15 of each 28 day cycle.
Sorafenib
For combination with DKN-01, sorafenib will be administrated according to standard clinical practice. Part A: After 8 weeks monotherapy with DKN-01, the study will be continued as combination therapy of DKN-01 and sorafenib until objective disease progression (PD) or unacceptable toxicity occurs. Part B:After PD1, study treatment will be continued as combination therapy of DKN-01 and sorafenib until disease progression (PD2) or unacceptable toxicity occurs.
RECRUITING
Universitätsklinikum Hamburg-Eppendorf, Hamburg
RECRUITING
Universitätsklinikum Schleswig Holstein Campus Lübeck, Lübeck
RECRUITING
Med. Hochschule Hannover, Hanover
RECRUITING
Universitätsklinikum Köln, Cologne
RECRUITING
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik, Mainz
RECRUITING
II. Medizinische Universitätsklinik Gastroenterologie, Hepatologie, Infektiologie, Mannheim
Collaborators (1)
Leap Therapeutics, Inc.
INDUSTRY
Johannes Gutenberg University Mainz
OTHER