545
Participants
Start Date
September 30, 2008
Primary Completion Date
November 30, 2012
Study Completion Date
August 31, 2013
Cilengitide
Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.
Temozolomide
Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] will be administered intravenously once daily from Weeks 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression.
Radiotherapy
Radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Weeks 1 to 6, total dose 60 Gy.
Please Contact U.S. Medical Information Located in, Rockland
Please Contact the Merck KGaA Communication Center Located in, Darmstadt
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono
INDUSTRY