Open-label regorafenib in patients with metastatic colorectal cancer

• Research type

  Research Study

• Full title

  An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy

• IRAS ID

  99059

• Contact name

  Mark Saunders

• Sponsor organisation

  Bayer Healthcare AG

• Eudract number

  2011-005836-25

• Research summary

  Metastatic colorectal cancer is cancer of the colon that has spread to other parts of the body. It is not currently curable with currently available therapies. Regorafenib is a compound that targets certain key proteins that are essential for the survival and growth of the cancer cells. Because of the way it works it may stop cancer growth. The purpose of this study is to provide regorafenib to patients diagnosed with metastatic colorectal cancer, in order to assess the safety of regorafenib (the study drug) and to assess how long the disease remains stable without getting worse. The study is considered research because regorafenib is under development and has not yet been approved by the UK regulatory authority for the treatment of metastatic colorectal cancer. Only patients aged 18 and over whose cancer has got worse after receiving all approved standard therapies can take part in the study. Up to 3000 patients worldwide in around 17 countries will take part in the study. This is an open-label single arm study which means that all participants in the study will receive the study drug, regorafenib. Regorafenib tablets will be taken orally (by mouth) once a day (4 tablets) in the morning for three weeks, followed by one week where no drug is taken. This treatment usually continues until the disease gets worse or the patient wants to stop treatment. During the study a number of assessments will be done, including: tumour assessments (in line with standard practice at the study centre) electrocardiogram, physical examinations and blood tests. If participant'stop treatment for any reason, they will need to return to the hospital/clinic within 14 days of permanently stopping treatment for a number of safety assessments. There will also be a safety follow-up 30 days after stopping treatment.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0242

• Date of REC Opinion

  30 May 2012

• REC opinion

  Further Information Favourable Opinion