
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
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 BYL719 for advanced . It is for people whose cancer cells have a change to a gene called PIK3CA .
In many types of cancer, the PIK3CA gene has changed (a ). This gene change affects a protein called P13K which is involved in cell growth.
BYL719 is a new drug that blocks the activity of the PI3K protein. We know from laboratory research that blocking this protein can stop the growth of several types of cancer. But this is the first time BYL719 is being tested in people.
The people taking part have that has the PIK3CA gene mutation, or has too many copies of the PIK3CA gene (amplification) and has got worse despite having other treatments. The aims of the trial are to
The trial also aims to find out if it is safe to have BYL719 at the same time as a drug called fulvestrant for breast cancer that is sensitive to the female hormone oestrogen () and has spread outside the breast.
You can enter this trial if you
You may be able to enter the part of the trial looking at BYL719 alongside fulvestrant if you are a woman who has with the PIK3CA gene mutation, that has spread outside your breast (metastatic breast cancer) and has come back or got worse despite having hormone therapy.
You cannot enter this trial if you
This is a phase 1 trial. Everybody taking part has BYL119 tablets. You take the tablets at about the same time each morning after a light breakfast. You must not eat or drink anything else for an hour afterwards.
The study is in 2 parts. In part 1, the first person has a low dose of BYL719. If they don’t have any bad 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.
In part 2, a larger number of people will have the highest safe dose that was found in part 1.
You take BYL719 tablets every day, but each 4 week period is called a treatment cycle. As long as you don’t have bad side effects, you can carry on taking the tablets until your cancer starts to get worse.
Some women taking part who have breast cancer will also have fulvestrant injections. You have the injections 2 weekly for the first 3 doses and then monthly.
The trial team will ask you to have 2 extra biopsies - before you start taking BYL719 and during the 2nd cycle of treatment. They will use these tissue samples, along with an extra blood sample, to look for markers that can show how well BYL719 is working. If you don’t want to have these biopsies, you don’t have to. You can still take part in the main trial.
You will see the doctors and have some tests before you start treatment. The tests include
You go to hospital
You have regular blood tests and a number of ECGs during the trial. At some hospital visits you have blood tests before taking the tablets and then at regular intervals over the next 24 hours. These blood samples will help the trial team to see how your body absorbs the drug, breaks it down and gets rid of it. This is called .
You have a CT or MRI scan every 8 weeks during treatment. And you have 2 more PET scans at the end of the 1st and 2nd cycles of treatment.
When you finish treatment, you go back to see the trial team about a week later. You have a physical examination including an eye test, blood tests, an ECG and a CT or MRI scan. You have one more follow up appointment with them about 3 weeks later.
This is the first time that BYL719 is being tested in people. There may be some side effects we don’t know about yet. The possible side effects include
You must not eat fruits such as grapefruit or Seville oranges (or drink their juices) during the trial as they may interact with the trial drug.
We have more information about possible side effects of fulvestrant in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Middleton
Experimental Cancer Medicine Centre (ECMC)
Novartis
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.