
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called LJM716 alongside trastuzumab (Herceptin) for HER2 positive cancer. It is for people who have breast cancer, stomach cancer or cancer where the food pipe (oesophagus) meets the stomach (gastro oesophageal junction cancer) that has spread to another part of the body.
Cancers with large amounts of a protein called are called HER2 positive cancers. Doctors can treat HER2 positive cancer with drugs such as trastuzumab (also known as Herceptin) which target the HER2 protein.
In this trial, researchers are looking at a drug called LJM716 alongside trastuzumab. LJM716 is a type of biological therapy called a monoclonal antibody. It stops signals that cancer cells use to divide and grow.
The aims of the trial are to
You may be able to enter this trial if
As well as the above
People joining the 2nd part of the trial must have cancer that can be seen on a CT scan, an MRI scan or a photograph of the skin and measures at least 1cm across.
You cannot enter this trial if
This phase 1 trial will recruit at least 55 people. Everybody taking part has trastuzumab and LJM716. You have both drugs through a drip into a vein once a week.
The trial is in 2 parts. In the 1st part, the researchers want to find the highest safe dose of LJM716. The first few patients taking part will have a low dose of the drug. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
In the 2nd part of the trial, the researchers want to learn more about LJM716 and whether it can stop or slow down the growth of HER2 positive cancers. Everybody joining this part of the trial has the highest safe dose found in part 1.
As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it is helping you.
You see the trial team and have some tests before you start treatment. The tests include
If your cancer has spread to your skin, the trial team will take a photograph. This will not include your face and it won’t be possible to identify you from the photo.
The researchers will get a sample of your cancer removed when you had surgery or a .
If you join the 1st part of the trial, they may ask you to have another biopsy before you start having LJM716. But you don’t have to have this biopsy if you don’t want to. You can still take part in the trial.
If you join the 2nd part of the trial, you must be willing to have another biopsy before you start having LJM716.
You go to hospital
You have regular blood tests and more heart traces throughout the treatment. You have a CT or MRI scan every 8 weeks. And if you have cancer spread to your skin, the trial team will also take photographs every 8 weeks.
People in the 2nd part of the trial may be asked to have 2 more biopsies. But these are optional. If you don’t want to have more biopsies, you can still take part in the trial.
Most hospital visits will last between 1 and 4 hours. A couple of visits early in your treatment will last 11 or 12 hours and you may need to stay in hospital overnight.
When you finish the treatment, the trial team will contact you a month later to see how you are.
If you stop the treatment for any reason other than your cancer getting worse, you continue to have a CT or MRI scan every 2 months until your cancer does start to get worse.
As LJM716 is a new drug, there may be side effects we don’t know about yet. The possible side effects include
To try to prevent a reaction, you have the LJM716 slowly over at least 2 hours. And you may have other medication such as paracetamol, an drug and
to reduce the risk of a reaction.
We have more information about the side effects of trastuzumab.
It is possible that the side effects of trastuzumab may be different when you have it at the same time as LJM716. The trial team will talk to you about all the possible side effects of the drugs before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Anthony Kong
Experimental Cancer Medicine Centre (ECMC)
Novartis
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”