1200.24 - BIBW 2992 QTcF Trial

• Research type

  Research Study

• Full title

  Phase II open label trial to assess the efficacy and the impact on QTcF of continuous oral BIBW 2992 at a daily dose of 50mg in patients with relapsed or refractory solid tumours including patients with brain metastases and those with glioblastoma not amenable to other therapy

• IRAS ID

  11423

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2008-006288-36

• ISRCTN Number

  n/a

• Research summary

  This study is a phase II, open-label trial to determine the effectiveness and safety, in particular the cardiac (heart) safety, of BIBW 2992, an epidermal growth factor (EGFR) inhibitor, in treating patients with solid cancers, including patients whose solid cancer has spread to the brain (brain metastases), and patients with glioblastoma (primary brain cancer). Patients to be entered into this trial are to have tumours that are known to be positive for the expression of the proteins EGFR and/or human epidermal growth factor 2(HER2). In addition, this study will determine whether BIBW 2992 has an effect on the function of the heart. This will be investigated by performing electrocardiograms (ECGs) and measuring heart function in patients receiving BIBW 2992 at key timepoints after taking BIBW 2992. Specific ECG measurements with the most important being the'QTcF' interval will be assessed in this trial.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  09/H0806/1

• Date of REC Opinion

  16 Mar 2009

• REC opinion

  Further Information Favourable Opinion