BEZ235 vs placebo pNETs after failure of mTOR inhibitor therapy
Research type
Research Study
Full title
A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR nhibitor therapy
IRAS ID
111656
Contact name
Nicholas (Nick) Reed
Contact email
Eudract number
2012-000675-16
Clinicaltrials.gov Identifier
Research summary
This clinical trial research study aims to find out if the study drug BEZ235 is safe and has beneficial effects in advanced pancreatic neuroendocrine tumours (pNETs) patients who have previously been treated with a mTOR inhibitor. 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. The study is split in two stages. If the results for stage 1 are postive, then Stage 2 will open. In Stage 1 of the study, patients will recieve BEZ235 and in Stage 2 patients will be randomly assigned to one of two treatment groups: BEZ235 or placebo. During the treatment period, patients will be asked to visit the hospital 4 times during the first month and then 2 times each month. The number of visits patients will be asked to attend is more than normal, and some of the visits will involve them attending the clinic for longer. Patients will continue to receive study treatment as long as the cancer is not growing and they can tolerate the drug. Initially 30 patients will be enrolled into the Stage 1 of the study at selected centres in the UK and other countries. If the results are positive, additional 99 will be enrolled into Stage 2. So far more than 280 patients with different types of tumours have received BEZ235, either alone or in combination with another anti-cancer drug. This trial is sponsored by the pharmaceutical company named Novartis.
REC name
West of Scotland REC 1
REC reference
12/WS/0180
Date of REC Opinion
19 Sep 2012
REC opinion
Further Information Favourable Opinion