7
Participants
Start Date
September 30, 2009
Primary Completion Date
August 31, 2012
Study Completion Date
June 30, 2014
racotumomab
Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), subcutaneously, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and a second line therapy is indicated, the patient will only be able to continue in the study if the drug indicated is docetaxel. Vaccination will not be interrupted during docetaxel administration unless criteria for vaccine discontinuation are met.
Best support treatment
Patients will receive best support treatment as indicated by the investigator. In case a second line therapy is indicated, docetaxel is the only drug allowed to continue in the study.
"Instituto de Oncología Angel H. Roffo", Buenos Aires
Lead Sponsor
Laboratorio Elea Phoenix S.A.
INDUSTRY