A trial looking at drugs called LJM716 and BYL719 for cancer of the food pipe

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

Cancer type:

Oesophageal cancer

Status:

Closed

Phase:

Phase 1/2

This trial is looking at 2 new drugs LJM716 and BYL719 for cancer of the food pipe (oesophageal cancer). This trial is for people with oesophageal cancer that has come back after treatment or has spread.

Doctors often use chemotherapy to treat oesophageal cancer. They may use a combination of chemotherapy drugs including a platinum drug Open a glossary item . Unfortunately for some people their cancer may not respond to this treatment or may come back afterwards. Doctors are looking for ways to treat these people.

LJM716 is a type of biological therapy called a monoclonal antibody. It seeks out cancer cells by looking for particular proteins.

BYL719 is also a type of biological therapy. It is a cancer growth blocker . It stops signals that cancer cells use to divide and grow.

The researchers think that having LJM716 and BYL719 may help people whose oesophageal cancer has come back after treatment or has spread.

This trial is in 2 parts. In the first part the researchers want to find the highest safe dose of LJM716 and BYL719 to give. In the second part they want to compare LJM716 and BYL719 with chemotherapy to find out which is better for treating oesophageal cancer that has spread or come back after it was first treated.

Who can enter

This trial is in 2 parts.

You can join both parts of this trial if all of the following apply

You have oesophageal cancer that is the squamous cell type
Your cancer has spread to another part of your body or has come back after treatment
You have had platinum drug chemotherapy. If you had this treatment for cancer that had spread into the surrounding tissue only, the cancer must have come back within 6 months
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 2 reliable forms of contraception during treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant
You are at least 18 years old

To join part 2 of this trial you must also have an area of cancer that can be measured on a scan and have had no more than 1 type of chemotherapy treatment.

You cannot join this trial if any of these apply

Your cancer has spread to your brain or spinal cord
You have had an anti cancer drug in the past 3 weeks (6 weeks for a nitrosourea or mitomycin C)
You have had radiotherapy in the past 4 weeks or still have side effects from radiotherapy
You have had radiotherapy to about a third of bone marrow (your doctor can tell you this)
You have had major surgery in the past 2 weeks or have not recovered from major surgery
You have had another cancer in the past 2 years apart from successfully treated basal cell skin cancer or carcinoma in situ of the cervix
You test positive for HIV
You have certain heart problems (the trial team can advise you about this)
You have diabetes and use insulin
You have moderate to severe diarrhoea
You are unable to swallow tablets
You have problems with your digestive system that would make it difficult for you to absorb tablets
You have had drugs that work in the same way as LJM716 and BLY719 (your doctor can tell you this)
You are sensitive to LJM716, BYL719 or their ingredients
You are pregnant or breastfeeding

As well as the above you cannot join part 2 of this trial if you have had squamous cell cancer Open a glossary item of the head and neck .

Trial design

This is an international phase 1/2 trial. The researchers need 15 people to join the phase 1 part and 84 people to join the phase 2 part.

In the phase 1 part everyone will have LJM716 and BYL719. The first few people taking part will have a low dose of LJM716 and BYL719. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

The phase 2 part 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.

People in group 1 will have LJM716 and BYL719
People in group 2 it will be their doctor’s choice

11205 trial diagram

You have LJM716 as an injection into a vein once a week. You have it over 2 hours. BYL719 are capsules. You take them every day.

For people in group 2 your doctor can choose to give you one of the following chemotherapy drugs

You have these drugs as an injection into a vein. Your doctor will talk to you about which is the best for you and how often you have it.

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

If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item . If this isn’t available you must agree to have a fresh sample of your cancer taken to take part in this trial.

The research team will ask people having LJM716 and BYL719 for some extra blood samples during their treatment. They will use these samples to find out about what happens to LJM716 and BYL719 in the body. They will also look for substances (biomarkers) in the blood to find out how the treatment is working.

Hospital visits

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

A physical examination
Blood tests
Heart trace (ECG )
Heart scan (ECHO or MUGA )
CT scan or MRI scan
Bone scan (if needed)
Eye examination (for people having LJM716 and BYL719)

You see the doctor once a week for the first 6 weeks of treatment. Each time you have a physical examination, blood tests and heart trace. You then see the doctor every 3 weeks for the same tests. You have a CT scan or MRI scan every 6 weeks.

After stopping treatment you see the doctor within 2 weeks for the same tests you had at the start. The researchers will then contact you a month afterwards to see how you are.

Side effects

Both LJM716 and BYL719 are new drugs and there may be side effects we don’t know about yet. The most common side effects of LJM716 reported so far include