16
Participants
Start Date
September 30, 2009
Primary Completion Date
August 31, 2010
Study Completion Date
August 31, 2010
Tecemotide (L-BLP25) and Hormonal Treatment
"Investigational Arm:~Pretreatment (Single Dose) 300 mg/m\^2 of intravenous cyclophosphamide in investigational arm to a maximum of 600 milligrams (mg).~Primary treatment phase:~Hormonal treatment plus 8 consecutive weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* (Week 1 to 8).~Maintenance treatment phase:~Hormonal treatment plus vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms)\* at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD).~\*calculated as mass of lipopeptide (antigen)"
Placebo of tecemotide (L-BLP25) and Hormonal Treatment
"Control Arm:~Pretreatment (Single Dose) NaCl 9 g/L infusion as a substitute for cyclophosphamide.~Primary treatment phase:~Hormonal therapy plus 8 consecutive weekly subcutaneous placebo doses (Week 1 to 8).~Maintenance treatment phase:~Hormonal therapy plus placebo doses at six-week intervals beginning at Week 14 and continued until Progressive Disease (PD)."
cyclophosphamide
300 mg/m\^2 (to a maximum of 600 mg) of intravenous cyclophosphamide.
sodium chloride (NaCl)
NaCl 9 g/L infusion
Research Site, Hickory
Research Site, Bedford Park, SA
Research Site, Innsbruck
Research Site, Salzburg
Research Site, Leuven
Research Site, Pardubice
Research Site, Prague
Research Site, Chemnitz
Research Site, Darmstadt
Research Site, Frankfurt am Main
Research Site, Hamburg
Research Site, Kiel
Research Site, Lübeck
Research Site, München
Research Site, Rostock
Research Site, Tübingen
Research Site, Wiesbaden
Research Site, Beer Yaakov
Research Site, Opole
Research Site, Obninsk
Research Site, Saint Petersburg
Research Site, Tula
Research Site, Bratislava
Research Site, Nitra
Research Site, Poprad
Research Site, Trnava
Research Site, Johannesburg
Research Site, Gyeonggi-do
Research Site, Seoul
Lead Sponsor
EMD Serono
INDUSTRY