BEZ235 or Everolimus in advanced pancreatic neuroendocrine tumours
Research type
Research Study
Full title
Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors
IRAS ID
98930
Contact name
Juan Valle
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-000769-19
Research summary
This study aims to find out if the study drug BEZ235 or everolimus is safe and has beneficial effects in patients who have advanced pancreatic neuroendocrine tumours (pNETs). The treatment aim is to shrink tumour size or stop the progression of the disease. This assessment will be based on measuring changes in the size of the tumour. Patients who qualify for the study will be randomly assigned to one of two treatment groups: BEZ235 or Everolimus. During the treatment period, patients will be asked to come to the hospital every 2 weeks for 8 weeks and thereafter every 4 weeks for medical assessments. The number of visits patients be will be asked to attend is more than normal, and some of the visits will involve them attending the clinic for longer. Approximately 140 patients from around the world will be asked to participate in this research study. 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. So far more than 280 patients with different types of tumours have received BEZ235, either alone or in combination with another anti-cancer drug.
REC name
North West - Haydock Research Ethics Committee
REC reference
12/NW/0555
Date of REC Opinion
20 Aug 2012
REC opinion
Favourable Opinion