A trial looking at BEZ235 for advanced neuroendocrine tumours of the pancreas

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Neuroendocrine tumour (NET)

Status:

Closed

Phase:

Phase 2

This trial is comparing a new drug called BEZ235 with everolimus for pancreatic neuroendocrine tumours (NETs). This trial is for people who have pancreatic NETs that can’t be removed with surgery or has spread to another part of the body. Doctors call this an advanced pancreatic neuroendocrine tumour.

Everolimus is a biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

BEZ235 is also a biological therapy. It too is a cancer growth blocker. It blocks more signals than everolimus does. The researchers think that BEZ235 may work better than everolimus to treat people with advanced pancreatic NETs.

The aims of this trial are to compare BEZ235 with everolimus to find out

Which is the better treatment for people with advanced pancreatic NETs
How safe BEZ235 is

Who can enter

You may be able to enter this trial if

You have a pancreatic neuroendocrine tumour (NET) that can’t be removed with surgery or has spread to another part of your body
You have a scan that shows your tumour has grown in the past year
Your tumour can be measured on a scan
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have satisfactory blood test results
You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if

You have a high grade NET, adenocarcinoid, goblet cell carcinoid or small cell carcinoma – your doctor can confirm this
You have had drugs that work in the same way as BEZ235 and everolimus – your doctor can confirm this
You have had more than 2 different courses of treatment with anti cancer drugs
You are allergic to the drugs in this trial
You have taken any anti cancer drugs in the past month, including as part of a clinical trial
You have had radiotherapy to a large area of your body or to a quarter of your bone marrow in the past month or had radiotherapy to a small area to control symptoms in the past 2 weeks
You still have side effects from radiotherapy
You have had major surgery in the past 2 weeks or still have side effects from previous surgery
Your tumour has spread to your liver and you have had chemotherapy directly into the area of spread (chemoembolisation), cryotherapy or radiofrequency ablation in the past 2 months
You had another cancer in the past 3 years apart from successfully treated in situ carcinoma of the cervix or non melanoma skin cancer
You have had a heart attack in the past 6 months or any other serious heart problem
You have high blood pressure or diabetes that isn’t controlled with medication
You have problems absorbing drugs from your gut
You are taking high dose steroids or any other medication that damps down your immune system
You are taking medication that affects the CYP3A enzyme – your doctor can confirm this
You are taking medication that causes a certain heart rhythm called Torsades de Pointes – you can ask your doctor about this
You are taking medication to thin your blood such as warfarin
You are HIV positive
You have moderate to severe diarrhoea
You have any other medical condition that could affect you taking part in this trial
You are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. It will recruit 140 people from different countries around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Half the people will have BEZ235. The other half will have everolimus.

BEZ235 for advanced neuroendocrine tumours of the pancreas trial diagram

BEZ235 is a powder. You dissolve it in a glass of water or apple juice. You take it twice a day after a light meal.

Everolimus is a tablet. You take it once a day at the same time, with a glass of water.

You can continue treatment as long as it is helping you and the side effects aren’t too bad.

On the days you visit the hospital you cannot eat or drink anything for 12 hours before, apart from water.

As part of this trial, the researchers will ask for a sample of tissue taken when you had surgery, or from a small piece of tissue taken to diagnose your cancer (a biopsy Open a glossary item ).

They will also ask for another biopsy if you agree and your doctor thinks it is OK. You don’t have to have this biopsy done if you don’t want to. You can still take part in the trial.

Hospital visits

You see the doctor to have tests before taking part in this trial. These tests include

A physical examination
Blood tests
Urine test
Heart trace (ECG )
Heart scan (ECHO or MUGA )
CT scan or MRI scan
Bone scan – if needed

During treatment you see the doctor every week for 2 months and then once every month. At each visit you have a physical examination and blood tests. You have a heart trace every month and a scan every 3 months.

At the end of treatment you see the doctor for the same tests you had at the beginning.

After treatment you see the doctor every 3 months. If you stopped taking your trial treatment due to side effects, you have a CT or MRI scan until you start another treatment or your tumour starts to grow again.

Side effects

BEZ235 is a new drug and there may be side effects we don’t know about yet. The most common side effects include

Tiredness
Feeling weak
Diarrhoea
Feeling or being sick
Tummy (abdominal) pain
Sore mouth
Loss of appetite and taste changes
Rash or itchy skin
Not having enough fluid in your body (dehydration )
A drop in blood cells causing an increased risk of infection, bruising or bleeding
A change to the way your liver works

You cannot eat or drink the juice of grapefruit, Seville oranges or other certain citrus fruits for a week before starting BEZ235 and during treatment.

The most common side effects of everolimus are