Cilengitide in Newly Diagnosed Glioblastoma

• Research type

  Research Study

• Full title

  Cilengitide for subjects with newly diagnosed glioblastoma multiforme and methylated MGMT gene promoter - 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 alone (CENTRIC).

• IRAS ID

  3252

• Contact name

  Roy Rampling

• Sponsor organisation

  Merck KGaA

• Eudract number

  2007-004344-78

• Clinicaltrials.gov Identifier

  00689221

• Research summary

  This research study is aiming to develop a novel treatment for a type of brain tumour (glioblastoma).The study drug, cilengitide, targets not only the tumour cells, but also and in particular, the blood vessels supplying the tumour with nutrients and oxygen. This new agent has shown some promising activity in preliminary studies in patients with recurrent brain tumours as well as in combination with standard chemotherapy and radiotherapy in patients with newly diagnosed glioblastoma.This study aims at demonstrating that the addition of cilengitide in combination with standard treatment prolongs life in patients with glioblastoma. Similarly, the duration of response of the cancer to this treatment, the side effects of the therapy and the impact on quality of life will be analyzed. In addition, further data on how well cilengitide is tolerated by the body and how the body deals with this substance will be collected.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/167

• Date of REC Opinion

  5 Mar 2009

• REC opinion

  Further Information Favourable Opinion