"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of AT13148 for advanced solid tumours
This trial is looking at a new drug called AT13148 for solid tumours that have continued to grow despite other treatment. A
More about this trial
AT13148 is a drug called an AGC kinase inhibitor. It blocks a number different chemical messages that are part of the signalling process within cells. We know from laboratory research that AT13148 can block these messages and stop cancer cells growing. But this is the first time AT13148 has been tested in people.
The aims of the trial are to
- Find the highest dose of AT13148 you can have safely
- Learn more about the side effects and what happens to the drug in your body (
- See if AT13148 can help people with solid tumours
Who can enter
You may be able to enter this trial if you
- Have a solid tumour that has got worse despite having other treatments or there is no other treatment that you can have
- 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 and your lungs are working well (you will have tests called
lung function teststo measure this)
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 6 months after finishing treatment if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain and is causing symptoms (you may be able to take part if you have cancer spread to your brain if it has not got any worse for more than 3 months)
- Have had radiotherapy in the last 4 weeks, unless it was to control symptoms (palliative radiotherapy) or you’ve had radiotherapy to more than a quarter of your
bone marrowin the last 8 weeks (your doctor can advise you about this)
- Have had hormone therapy in the last 4 weeks apart from drugs such as Zoladex for prostate cancer
- Have had
immunotherapyor chemotherapy in the last 4 weeks (6 weeks if you had a drug called mitomycin C or a drug called a nitrosourea)
- Have not recovered from the side effects of other treatment (apart from hair loss) unless they are very mild
- Have not fully recovered from surgery to your chest or the area between your ribs and your hips (your
- Have had a
bone marrow transplant
- Are having an experimental treatment as part of another clinical trial
- Have ever had a disease affecting your immune system called an
- Have a condition affecting your lungs called interstitial lung disease
- Have very low blood pressure (the trial doctors will test this) or you take medication for high blood pressure
- Have heart problems that are a cause for concern
- Have diabetes and need to take medication to control it
- Have an infection that cannot be controlled with medication, or any other medical condition that would make it unsafe for you to take part
- Are allergic to peanuts
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
This phase 1 trial will recruit about 60 people at The Royal Marsden Hospital in Sutton, Surrey.
The first people taking part will have a low dose of AT13148. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until the researchers find the highest dose they can safely give. This is called a dose escalation study. Then 10 people will have the highest safe dose to learn more about how the drug works.
AT13148 is a capsule that you swallow. You take it up to 3 times a week. The number of days you take it will depend on the dose you have. The trial team will explain more about how and when you take the capsules.
If tests show that your cancer is not growing, you can take AT13148 for up to a year. If it is still helping you at the end of the year, the trial team may talk to you about taking it for up to another year.
If you are 1 of the 10 people having the highest safe dose, the study team may ask you to have a PET-CT scan in the week before your first dose of AT13148. On the same day, you will also have a type of MRI scan called a diffusion weighted MRI (DW MRI). DW MRI scans give doctors more information about what is happening inside the cancer. You have more PET-CT and DW MRI scans 2 and 4 weeks after starting treatment.
You will see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood and urine tests
- CT scan
- MRI scan
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- Tests to see how well your lungs are working (lung function tests)
The trial team may ask to take a small sample of your cancer (a
The trial doctor will pluck 4 of your eyebrow hairs to learn more about how AT13148 affects your body. If you do not have enough eyebrow hair for this test you can still take part in the study
The following week, you start taking AT13148 up to 3 times a week. In this first week of treatment, you go to hospital each time you take the capsules so the trial team can monitor you for a few hours.
After the first week of treatment, you go to hospital once a week and take the capsules at home on the other days. After the first 2 months of treatment, you may only need to go to hospital once every 2 weeks, and after 6 months only once a month.
At each of these hospital visits you see the trial team, have blood and urine tests and take your capsules. You will be at the hospital for at least 4 hours each time as the trial team need to monitor you closely for a few hours.
During your first 2 months of treatment, you have a number of blood tests before and after you take your capsules. This is so the doctors can see what happens to the drug in your body. On two occasions, you may need to stay in hospital for at least 1 night, possibly 2.
During the first 4 to 6 weeks of treatment, you use a monitor to take your blood pressure at home a couple of times a day. You record this in a diary.
The researchers will take more samples from your eyebrows on another 2 occasions during your first six weeks of treatment.
If you agreed to have a biopsy before treatment, the trial team will ask you to have another one after 2 to 3 weeks of treatment.
During treatment, you have lung tests, ECGs and heart scans if your doctor thinks it is necessary. You have a CT or MRI scan every 8 weeks
After you finish treatment, you see the trial team again 2 weeks later. You have blood and urine tests, a heart trace, heart scan, lung tests and a CT or MRI scan if you have not had one recently.
If you are still having side effects, you carry on seeing the trial team until they get better. If your cancer had stopped growing, then started to grow again, the trial team may ask you to have a biopsy.
As AT13148 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
- Low blood pressure which may cause flushing and dizziness
- An increase in your heart rate
- Shortness of breath or chest pain
- A build up of fluid in your chest
- Skin rash
- Sore mouth
- High levels of sugar in your blood which can make you need to pass urine frequently, and cause symptoms such as drowsiness, feeling sick, extreme hunger or thirst, and blurred vision
- Low levels of sugar in your blood which can make you pale, feel weak or hungry, have a higher heart rate than usual, blurred vision, confusion and a temporary loss of consciousness
Women may have changes to their periods (
It is important that you let the trial doctors know about any side effects you have.
During the trial, you cannot take any other drugs that could affect an enzyme called CYP3A4 as this could affect how your body breaks down AT13148. The trial team will explain this to you.
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.
Dr Udai Banerji
Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust