Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of BKM120 for advanced non small cell lung cancer
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at BKM120 for people who have non small cell lung cancer that has spread. To enter the trial, your lung cancer cells must have changes to a cell signalling system called the PI3K pathway.
If non small cell lung cancer spreads to another part of your body, you may have chemotherapy. But the cancer can get worse or come back after having chemotherapy. Researchers are looking for new drugs to help people in this situation. In this trial, they are looking at a drug called BKM120.
PI3K proteins do a number of different things, such as sending signals to tell cancer cells to grow. This is called the PI3K pathway. In some cancers PI3K is permanently switched on (activated), which means that the cancer cells grow and reproduce uncontrollably. People taking part in this study have an activated PI3K pathway. Researchers hope that blocking PI3K proteins may help stop cancer cells from growing.
The aim of this trial is to see if BKM120 helps people who have non small cell lung cancer that has come back, despite having other treatment, and where the lung cancer cells have changes to the P13K pathway.
Who can enter
You may be able to enter this trial if you
- Have non small cell lung cancer that has spread to other parts of your body and the PI3K pathway is activated (the trial team will test for this)
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the trial and for 3 months after if there is any chance you or your partner could become pregnant
- Are at least 18 years old
As well as all the above, your cancer must have got worse despite having chemotherapy
- If your cancer is squamous cell cancer, you can have had only had 1 type of chemotherapy that included a
platinum drugfor cancer that has spread or
- If you have another type of non small cell lung cancer, you can have had 1 or 2 other types of treatment for cancer that has spread – if your cancer was tested for a gene change that affects a growth factor called EGFR this must include at least 1 drug called a tyrosine kinase inhibitor such as erlotinib or gefitinib
You cannot enter this trial if you
- Have cancer that has spread to your brain or spinal cord and has not been treated or is causing symptoms (you can take part if you had treatment for cancer spread to your brain at least 2 weeks ago, it is not causing symptoms and if you are taking steroids, you have been on a low, stable dose for at least 2 weeks)
- Have already had a drug that blocks PI3K
- Are currently having any other type of cancer drug
- Have not recovered from the side effects of other cancer drugs (apart from hair loss) unless they are very mild
- Have had radiotherapy in the last 4 weeks, or earlier if you have not fully recovered from any side effects
- Have had surgery in the last 4 weeks, or earlier if you have not fully recovered
- Have had mental health problems such as severe depression or anxiety
diabetesthat is not well controlled with medication
- Have had any heart problems that are a cause for concern or take other medication that can affect your heart rhythm – the trial doctors can advise you about this
- Have any problems with your
digestive systemthat could affect how you absorb tablets
- Have been taking
steroidsor other medication that damps down your immune system(you can take part if you use steroid creams, inhalers or eye drops)
- Take drugs that can affect a group of enzymes called CYP3A – the trial doctors can explain this
- Take a blood thinning medicine called warfarin or a similar drug
- Have had any other type of cancer in the last 5 years apart from non melanoma skin cancer or cervical cancer that was completely removed with surgery
- Have any other serious medical condition that the trial doctors think could affect your taking part
- Are known to be HIV positive
- Are pregnant or breastfeeding
As well as the above, you cannot join the 2nd part of the trial if you have squamous cell cancer and have already had a drug called docetaxel, or you have other types of non small cell lung cancer (non squamous) and have already had docetaxel and a drug called pemetrexed.
This international phase 2 trial will recruit about 180 people around the world.
Before you can join the trial, the researchers will test to see if your cancer cells have changes to the PI3K pathway. To do this, they need a sample of your lung cancer. They may be able to get a sample that was removed when you had surgery or a
The trial is in 2 parts. In the 1st part of the trial, everybody has BKM210 capsules. You take them by mouth once a day. The trial team will give you more information about exactly how and when to take the capsules.
In the 2nd part of the study, some people will have BKM120, some will have chemotherapy. This part of the study is randomised. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. There will be twice as many people in the BKM120 group as in the chemotherapy group.
If you have chemotherapy, you have either docetaxel or pemetrexed. Your doctor will decide which drug you have, depending on the type of non small cell lung cancer you have. In this trial, you have chemotherapy through a drip into a vein once every 3 weeks. It takes about an hour each time.
The trial team will ask you to fill out a questionnaire once every 3 weeks during treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
As long as you don’t have bad side effects, you can carry on having treatment for as long as it helps you. If you are in the chemotherapy group and your cancer gets worse, it may be possible for you to then have BKM120. The trial doctor will discuss this with you at the time.
Depending on where the cancer is in your lung, the trial team may ask you to have another
You will see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood and urine tests
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- CT scan or MRI scan
You may also have a bone scan.
During the trial treatment, you go to hospital to see the trial team every 10 days. You have regular blood tests and ECGs. You have a CT or MRI scan every 6 weeks and a MUGA or echocardiogram every 12 weeks.
At some hospitals, doctors will take extra blood samples to learn more about what happens to BKM120 in your body. This is called
When you finish having treatment, you see the trial doctors again and have more tests and scans. After that, a member of the trial team will contact you every 2 months to see how you are.
As BKM120 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
- High blood sugar
- Skin rash and itching
- Sore mouth
- Tiredness (fatigue)
- General discomfort
- Diarrhoea or constipation
- Tummy (abdominal) pain
- Changes to your liver
- Feeling or being sick
- Loss of appetite
- Changes to your mood, such feeling anxious, depressed or irritable
In earlier trials, some people taking BKM120 had such significant changes in their mood (including anxiety and depression) that they had to stop taking the drug. Researchers don’t fully understand why these changes happen and the impact they have on people. But at some hospital visits they will ask you to fill in questionnaires about how you are feeling (your mood), so they can monitor this.
The side effects of the chemotherapy drugs in this trial include tiredness (fatigue) and a drop in blood cells causing an increased risk of infection, bleeding problems and breathlessness. We have more information about the possible side effects of docetaxel and pemetrexed.
How to join a clinical trial
Dr Rohit Lal
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)