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Merck at ASCO 2007: Encouraging Results in Progression-Free,Survival in Patients With Aggressive Brain Tumors (glioblastoma),Using Cilengitide in Phase I/IIa Study

malignant brain tumors. Of these, 50% are glioblastomas, the most aggressive type of brain tumor.

Average survival time for newly diagnosed glioblastoma patients receiving the current best available treatment is only 12-15 months.(1) Glioblastomas currently have a near 80% mortality rate within two years, irrespective of the treatment. It is therefore essential that novel treatment options and in particular, targeted therapies such as cilengitide, are investigated.

About the studies
Study 1 (newly diagnosed glioblastoma) is a multicenter, open-label, uncontrolled Phase I/IIa study investigating cilengitide and temozolomide with concomitant radiotherapy, followed by temozolomide and cilengitide maintenance therapy in patients with newly diagnosed glioblastoma. After tumor resection or biopsy, patients were treated with standard temozolomide and radiotherapy. In addition, cilengitide (500mg, iv, twice per week) was started one week before temozolomide and radiotherapy and given throughout for the duration of chemotherapy or until disease progression. The primary endpoint was progression-free survival at six months. The study was conducted at 16 centers in Germany, Switzerland and Belgium.

Study 2 (recurrent glioblastoma) is a multicenter, open-label, randomized, uncontrolled Phase IIa study investigating cilengitide as a single agent in patients with recurrent glioblastoma. Patients were randomized to receive either 500mg or 2000mg of iv cilengitide twice per week until disease progression. The primary endpoint was progression-free survival at six months. The secondary endpoints included response rate, survival, time to disease progression, safety, tolerability and pharmacokinetics. The study was carried out at 15 centers in the US.

About cilengitide
Cilengitide was developed by Merck. It is the first in a new class of targeted anti-cancer therapies in glioblastoma – known as integrin inhibitors – that are thought t
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