N021895 RAF/MEK Inhibitor study in patients with advanced solid tumors

• Research type

  Research Study

• Full title

  Open-label, multicenter, dose-escalation Phase I/II study to evaluate safety, pharmacokinetics and activity of RO5126766, a dual Raf and MEK inhibitor, administered orally as monotherapy in patients with advanced tumors

• IRAS ID

  6226

• Contact name

  Udai Banerji

• Sponsor organisation

  F Hoffmann La Roche

• Eudract number

  2008-002298-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This clinical research study with RO5126766 is being sponsored by Roche Products Ltd and is under the direction of Dr Banerji and his study staff. The purpose of this research is to find out the safest dose of the medication to be administered to patients with advanced cancer for whom no standard treatment is available. If the first dose of RO05126766 is safe, each new group of patients will receive a higher dose of the drug than the previous group. We are doing this to understand what dose we can give without serious side effects. Once the highest dose(s) of RO05126766 that are tolerable will be selected, about 45-60 additional patients will be treated at these dose(s). About 75-100 patients in total are expected to participate in the study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  08/H0801/139

• Date of REC Opinion

  18 Dec 2008

• REC opinion

  Further Information Favourable Opinion