Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of AZD0424 for advanced solid tumours
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 AZD0424 for solid tumours. It is for people who have a
More about this trial
AZD0424 is a type of biological therapy. It works by slowing down or stopping the activity of proteins called Src and ABL1. These proteins are involved in various parts of cell growth.
We know from laboratory research that AZD0424 can stop cancer cells growing. But this is the first time AZD0424 has been tested in people.
The aims of the trial are to
- Find the highest dose of AZD0424 you can have safely
- Learn more about the side effects and what happens to the drug in your body
When the researchers find the highest dose of AZD0424, they will give this dose to at least 6 people.The researchers may continue the trial to look at up to another 6 people having this dose and then more people having AZD0424 alongside other drugs. They will not decide whether to do this or which other drugs to look at until they have results from this first part of the trial.
Who can enter
You may be able to enter this trial if you
- Have a
solid tumourthat has continued to grow despite all other available treatments or you have a cancer for which there is no standard treatment
- 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 at least 18 years old
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance that you or your partner could become pregnant
If you join the trial when researchers are giving people the highest dose being looked at in this trial, you must have an area of cancer that they can safely take a tissue sample (
You cannot enter this trial if you
- Have cancer that has spread to your brain, unless this was treated at least 3 months ago, has not got worse since then and is not causing symptoms
- Have had radiotherapy (apart from radiotherapy for symptoms) in the last 4 weeks
- Have had chemotherapy, hormone therapy or
immunotherapyin the last 4 weeks (6 weeks if you had chemotherapy drugs called nitrosureasor mitomycin)
- Have not recovered from the side effects of other treatments (apart from hair loss) unless they are very mild
- Have not yet recovered from major surgery to your chest or tummy (
- Have a lung condition called interstitial lung disease
- Have low blood pressure or certain heart problems – the trial doctors can advise you about this
- Have an infection that cannot be controlled with medication or any other serious medical condition that the trial doctors think could affect you taking part
- Are taking part in a clinical trial looking at another experimental treatment
- Are known to be HIV, hepatitis B or hepatitis C positive
- Are allergic to peanuts
- Are pregnant or breastfeeding
If you take a drug called trazadone, you can't take part in the trial unless you are able to take a different drug for the first 5 weeks of the study - your doctor can advise you about this and it is important that you don't stop taking any medication before talking to them.
This is a phase 1 trial. Everybody taking part will have AZD0424.
The first few patients will have a low dose of AZD0424. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until the researchers find the best dose to give. This is called a dose escalation study.
Once the researchers have found the highest dose of AZD0424 that at least 6 people had safely, they may give this dose to up to 6 more people to learn more about the effect the drug has on the body.
You take AZD0424 capsules each day. You must not eat, or drink anything apart from water, for 2 hours beforehand and 1 hour afterwards.
As long as it is helping, you can carry on taking AZD0424 for up to 11 months.
You will see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests and urine tests
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- CT scan or MRI scan (if you haven’t had one in the last 4 weeks)
You may have a special CT scan that takes very detailed pictures of your lungs (lung high resolution computerised tomography or HRCT) - your doctor will tell you if you need to have this scan.
If you are 1 of up to 6 people who join the trial when researchers are giving people the highest dose of AZD0424, you will also have to have a
You go to hospital to have your first dose of AZD0424. You must not eat anything from the night before. You go back for blood tests on the following 2 days.
You then take the capsules at home, but you go to hospital once a week for first 4 months of treatment. If everything is going well after the first 4 months, your hospital visits change to once every 2 weeks.
Throughout your treatment, you have regular blood tests. And you have a CT or MRI scan every 8 weeks.
When you finish treatment, you go back and see the trial team 4 weeks later. You have a physical examination, blood tests, urine tests, a heart trace and a CT scan. If you are having side effects, the trial team will continue to see you until these get better, or until you start another treatment.
As AZD0424 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
- Feeling or being sick
- Tummy (abdominal) pain
- Loss of appetite
- A drop in your blood pressure
- Changes to your heart or your liver
- Inflammation of your lungs that can cause a cough or shortness of breath
- Tiredness (fatigue)
- Skin rash and itching
- Hair loss or hair thinning
- A strange or bad taste in your mouth
- A drop in some types of blood cells causing an increased risk of infection and bleeding problems
If you have biopsies, you will have a local anaesthetic beforehand, but it may be a bit painful or uncomfortable afterwards. The after effects will depend on where in the body you have the sample taken from. There may be a small amount of bleeding and you may need to have some stitches. You have these removed after a few days.
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.
Professor Adrian Harris
Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer