MetMab combined with mFOLFOX6 in HER2 negative Met Positive GEC

• Research type

  Research Study

• Full title

  A randomised, phase III, multicentre, double-blind, placebo-controlled study evaluating the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) in patients with metastatic HER2 negative, met-positive gastroesophageal cancer

• IRAS ID

  106095

• Contact name

  David Cunningham

• Sponsor organisation

  F Hoffman-La Roche

• Eudract number

  2012-001402-23

• ISRCTN Number

  N/A

• Research summary

  For metastatic gastroesophageal cancer (GEC) patients unable to undergo surgery, the main treatment option is chemotherapy which may increase survival and improve quality of life. This study aims to determine whether treatment with onartuzumab (MetMAb) and chemotherapy is more effective than chemotherapy alone, in patients with metastatic gastroesophageal cancer that has low levels of the protein HER2 and high levels of the protein Met on the surface of the cancer cells (HER2 negative and Met positive). The study will also look at side effects and safety in these patients. A total of approximately 800 patients will be recruited into the study globally. There will be 2 treatment groups. Which treatment each patient gets will be decided by chance by a computer, not by the doctor. Patients will receive either treatment with MetMAb or placebo intravenously, followed by mFOLFOX6, every 14 days, for 12 cycles (each cycle is 14 days). mFOLFOX6 is a globally accepted standard drug regimen consisting of ?? oxaliplatin (given intravenously over 2 hours), leucovorin (a form of the vitamin folic acid that enhances the effect of 5-FU, given before the 5FU) and flurouracil (5-FU, given as an intravenous injection, followed by a continuous 46-48 hour infusion). Drug treatment with mFOLFOX6 will be stopped after 12 cycles, or sooner if the patient??s disease worsens. Study drug treatment with MetMAb or placebo could continue after 12 cycles if the cancer is responding to treatment. The drug treatment will be stopped when the patient??s cancer no longer responds to the treatment. Following the last dose of study drug treatment the patient will be contacted every 3 months to check on their health and wellbeing. The study will continue for approximately 3 years. In the UK it is expected that 30 patients will be enrolled at 6 participating study centres. The study is sponsored by F. Hoffman-La Roche Ltd.

• REC name

  London - South East Research Ethics Committee

• REC reference

  12/LO/1090

• Date of REC Opinion

  3 Sep 2012

• REC opinion

  Further Information Favourable Opinion