29
Participants
Start Date
March 31, 2013
Primary Completion Date
August 31, 2015
Study Completion Date
January 31, 2016
Atu027 & gemcitabine in lead in safety period
Subjects will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks.
Atu027 & gemcitabine in treatment arm 1
"Subjects will be treated in a 28-day cycle with Atu027 and gemcitabine once weekly for three consecutive weeks (on days 1, 8, and 15). During week four no treatment is administered.~Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs."
Atu027 & gemcitabine in treatment arm 2
"Subjects will be treated in a 28-day cycle with gemcitabine once weekly (on days 4, 11, and 18) and Atu027 twice weekly (on days 1, 4, 8, 11, 15, 18, 22, and 25). The 28-day combination cycle is followed by a 28-day gemcitabine monotherapy cycle.~Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs."
Charité - Universitätsmedizin Berlin Charité Centrum für Tumormedizin, Berlin
Klinikum Kassel GmbH Medizinischen Klinik IV;Onkologie,, Kassel
Klinikum Dortmund gGmbH Medizinische Klinik Mitte, Dortmund
Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne, Herne
Klinikum Stuttgart Klinik Hämatologie, Onkologie und Palliativmedizin, Stuttgart
Universitätsklinikum Freiburg, Innere Medizin II, Freiburg im Breisgau
Universitätsklinikum Ulm Zentrum für Innere Medizin, Ulm
Klinikum Nürnberg Nord Medizinische Klinik 5, Nuremberg
Klinik und Poliklinik für Innere Medizin I Universitätsklinikum Regensburg, Regensburg
Collaborators (2)
Granzer Regulatory Consulting & Services
OTHER
FGK Clinical Research GmbH
INDUSTRY
Silence Therapeutics GmbH
INDUSTRY