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:
Status:
Phase:
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 
. 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 of the .
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
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 . 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
- Tiredness
- Loss of appetite
- Low levels of potassium and magnesium in your blood
- Feeling or being sick
- Weakness
The most common side effects of BYL719 reported so far include
- Diarrhoea
- Tummy (stomach) pain
- Skin rash, redness and thinning of the skin
- Tiredness
- Excessive wind (flatulence)
- High levels of sugar in the blood
- High blood pressure
- Increased possibility of bruising
- Changes to the way your liver works
- Feeling or being sick
We have information about the side effects of
Your doctor will talk to you about the possible side effects of your treatment before you agree to take part in this trial.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Was Mansoor
Supported by
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
