BO21189-A Phase 1 study of RO4987655 in patients with advanced tumours

• Research type

  Research Study

• Full title

  Open-label, multicentre, dose-escalation Phase 1 study with extension to evaluate safety, pharmacokinetics and activity of RO4987655, a MEK inhibitor, administered orally as monotherapy in patients with advanced tumours

• IRAS ID

  9880

• Sponsor organisation

  F Hoffmann La Roche

• Eudract number

  2007-002021-77

• ISRCTN Number

  n/a

• Research summary

  This clinical study with RO4987655 is being sponsored by Roche Products Ltd and is under the direction of Prof Mark Middleton and his study staff. The purpose of the first part of the research was to find out the safest dose of the medication to be administered to patients with advanced cancer. Now this dose is known the research is going on to explore the effects of RO4987655 in patients with melanoma, lung cancer and bowel cancer. In total a further 50-80 patients are expected to participate in the study. Patients with lung or bowel cancer can only take part if their cancer has a genetic change (called a mutation) that might be counter-acted by the RO4987655. Patients taking part will receive the drug twice a day, and undergo blood tests, eye tests and scans to check the effects of RO4987655. Patients with melanoma are required to have a sample of their tumour taken before and after treatment.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/4

• Date of REC Opinion

  9 Feb 2009

• REC opinion

  Further Information Favourable Opinion