19
Participants
Start Date
November 30, 2009
Primary Completion Date
October 31, 2011
Study Completion Date
October 31, 2011
cabazitaxel
"Pharmaceutical form: 60 mg/1.5 ml concentrate solution for infusion~Route of administration: Intravenous infusion over 60 minutes~Dosage:~* Study part 1: 15, 20 or 25 mg/m\^2 according to pre-defined dose escalation schedule~* Study part 2: MTD as determined in Study part 1"
gemcitabine
"Pharmaceutical form: According to United States Package Insert (USPI)~Route of administration: Intravenous infusion over 30 minutes~Dosage:~* Study part 1: 700, 900 or 1000 mg/m\^2 according to pre-defined dose escalation schedule~* Study part 2: MTD as determined in Study part 1."
Investigational Site Number 840004, Philadelphia
Investigational Site Number 840001, Nashville
Investigational Site Number 840002, Detroit
Investigational Site Number 840005, Cincinnati
Lead Sponsor
Sanofi
INDUSTRY