Project
Cilengitide for subjects with newly diagnosed glioblastoma multiforme and methylated MGMT gene promotor - a multicenter, open-label, controlled phase III study, testing cilengitide in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) versus standard treatment (CENTRIC)
Completed · 2009 until 2013
Hundsberger Thomas
Type
Range
Units
Status
Start Date
End Date
Financing
Study Design
Keywords
Partner
Brief description/objective
A multicenter, open-label, controlled, Phase III study in
subjects with newly diagnosed GBM and with
methylated MGMT gene promoter, who will be
randomized in two groups as follows:
• Cilengitide group: cilengitide + radiotherapy
(RTX)/temozolomide (TMZ), followed by
cilengitide + TMZ (Cil+TMZ/RTX®Cil+TMZ).
• Control group: RTX/TMZ, followed by TMZ
(TMZ/RTX®TMZ; the so-called EORTC/NCIC
regimen).
Subjects in the cilengitide group will be treated with 2000 mg cilengitide (twice weekly, i.v.) in combination
with standard therapy for 8 months, followed by a 10
month cilengitide maintenance treatment. Subjects in
the control group will receive standard therapy for 8
months (6 weeks of RTX + TMZ, followed by 6 fourweeks-
cycles TMZ maintenance treatment).