90
Participants
Start Date
January 1, 2011
Primary Completion Date
February 11, 2013
Study Completion Date
August 1, 2013
BAY86-9766+Gemcitabine
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
Bruxelles - Brussel
Bruxelles - Brussel
Edegem
Berlin
Brescia
Marburg
Bochum
Ancona
Clermont-Ferrand
Heilbronn
Aurora
München
Pittsfield
Brno
Olomouc
Oslo
Oslo
London
Bialystok
Gdansk
Warsaw
London
London
Lead Sponsor
Bayer
INDUSTRY