1200.38 BIBW 2992 Glioblastoma Trial

• Research type

  Research Study

• Full title

  Phase I, open label trial to explore safety of combining BIBW 2992 and radiotherapy with or without temozolomide in newly diagnosed GBM

• IRAS ID

  21418

• Contact name

  Michael Brada

• Eudract number

  2008-007284-17

• ISRCTN Number

  N/A

• Research summary

  This study is a phase I, open label trial to determine the Maximum Tolerated Dose (MTD), safety, pharmacokinetics, and efficacy of BIBW 2992 (an epidermal growth factor receptor (EGFR) inhibitor) to be used in combination with: - radiotherapy alone (in patients with an unmethylated (functioning) MGMT gene regulator) or - radiotherapy and Temozolomide (in patients with a methylated (silenced) MGMT gene) to treat newly diagnosed patients with Grade IV Glioblastoma (primary brain cancer). The MGMT gene codes for a protein that repairs DNA. The gene can be turned on or off, depending on the methylation status of its regulator: methylated or unmethylated.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/58

• Date of REC Opinion

  27 Aug 2009

• REC opinion

  Further Information Favourable Opinion