Regorafenib with mFOLFOX6 in metastatic colorectal cancer

• Research type

  Research Study

• Full title

  An uncontrolled, open-label, phase II study in subjects with metastatic adenocarcinoma of the colon or rectum who are receiving first line chemotherapy with mFOLFOX6 (oxaliplatin/ folinic acid/5-fluorouracil [5-FU]) in combination with regorafenib

• IRAS ID

  69284

• Contact name

  James Cassidy

• Sponsor organisation

  Bayer Health Care AG

• Eudract number

  2010-020121-41

• Research summary

  This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth and leave good cells alone, unlike traditional chemotherapy. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, whether the disease is getting smaller. The aim is to show that the treatment of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only. The response rate for the standard therapy with mFOLFOX6 is assumed to be 40%. For the power calculation it is assumed, that under the alternative hypothesis the expected response rate for combination therapy (regorafenib plus mFOLFOX6) may be 60%.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/93

• Date of REC Opinion

  17 Jan 2011

• REC opinion

  Further Information Favourable Opinion