Everolimus in patients with non functioning NETs (RADIANT-4)

• Research type

  Research Study

• Full title

  A randomised, double-blind, multicentre, Phase III study of everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in the treatment of patients with advanced NET of GI or lung origin -RADIANT-4

• IRAS ID

  98327

• Contact name

  Juan Valle

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2011-002887-26

• Research summary

  Previous studies have shown that everolimus can help stop cancer cells from multiplying too much. This clinical research study is designed to find out if the drug everolimus is safe and has beneficial effects in patients who have advanced nonfunctional neuroendocrine tumours (i.e. neuroendocrine tumours without the so-called carcinoid syndrome with symptoms likfluhing or diarrhoea). Patients will be randomly assigned to one of two treatment groups: everolimus (active drug) or placebo (pill without medicine inside) and are twice more likely to receive everolimus than placebo. If everolimus is shown to be significantly effective then patients on the placebo arm will be allowed switch over to everolimus after the analysis. About 279 patients will join in this study at around 120 research clinics in several countries around the world. During the treatment period, patients will be asked to come to the hospital once every 4 weeks for medical assessments. These visits can last up to 2 hrs. Time to disease progression will be primary endpoint. This trial is sponsored by the pharmaceutical company named Novartis. Everolimus has been used to treat cancer patients in clinical studies since 2002 and approximately 13,000 patients with various types of cancer have been treated with everolimus.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0137

• Date of REC Opinion

  28 Feb 2012

• REC opinion

  Favourable Opinion