“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial of AZD1208 for solid tumours and lymphoma
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
A trial looking at AZD1208 for
Doctors use treatments such as surgery, radiotherapy, chemotherapy, hormone therapy and biological therapy to treat cancer. But sometimes cancers continue to grow despite having all the standard treatments. Researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a new drug called AZD1208.
AZD1208 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
The main aims of this study are to
- Find the highest dose of AZD1208 you can safely have
- Learn more about the side effects and what happens to AZD1208 in your body
- See how the drug affects lymphomas and solid tumours
Who can enter
You may be able to enter this trial if you
lymphomaor a solid tumourthat has got worse despite having other treatments, or there is no other standard treatmentavailable
- Have cancer or lymphoma that your doctors can see and measure on a scan
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are at least 18 years old
- Are willing to use reliable contraception during the trial and for 4 weeks afterwards if you are a woman who could possibly become pregnant – male patients must use a condom during the trial and for up to 3 months afterwards if there is any chance their partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your spine (spinal cord compression) or brain, unless this has been successfully treated, is not getting any worse or causing symptoms and you haven’t needed to take steroids for at least 4 weeks
- Have had an experimental drug as part of another clinical trial in the last 4 weeks
- Have already had AZD1208
- Have had any other cancer drugs in the last 3 weeks (6 weeks if you had a mitomycin C or a drug called a
- Have had major surgery in the last 4 weeks
- Have had radiotherapy to treat a large area of your body in the last 4 weeks, or radiotherapy to a small area to control symptoms in the last 2 weeks
- Have not recovered from side effects of earlier treatment (apart from hair loss) unless they are very mild
- Have had a heart attack in the last 3 months, or have certain other heart problems – the trial team can advise you about this
- Have problems with your
digestive systemthat could affect you swallowing or absorbing capsules
- Have hepatitis B, hepatitis C or HIV
- Have any other medical condition that can’t be controlled with medication
- Are known to be allergic to anything in AZD1208 or to similar drugs
- Are pregnant or breastfeeding
This phase 1 trial will recruit about 50 people. There are 2 parts to the trial – part A and part B. In part A, the researchers are trying to work out the best dose of AZD1208 to give.
Everybody taking part will have AZD1208. The first few patients have a low dose. If they don’t have any serious side effects, the next few patients have a higher dose. And so on, until the researchers find the highest dose that can be given safely. This is called a dose escalation study.
In part B, the researchers want to learn more about what happens to AZD1208 in your body, the side effects and how it affects your cancer or lymphoma. Everybody joining this part of the trial has the highest safe dose of AZD1208 that was found in part A.
You take AZD1208 capsules by mouth. You have a single dose of the drug and then between 3 and 7 days later you start taking it every day.
As long as you don’t have bad side effects, you can carry on having AZD1208 for as long as it is helping you.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Heart traces (
- Chest X-ray (if needed)
You must agree to the researchers getting a sample of your cancer or lymphoma that was removed when you had surgery or a
You go to hospital to have your first dose of AZD1208 and then on each of the following 2 days.
A few days later, you start taking the drug each day. You go to hospital 5 times in the first 3 weeks and then once a week after that. If you carry on taking AZD1208 for longer than 36 weeks, your hospital visits then reduce to once every 3 weeks. The trial team will give you more information about any tests and scans you need to have at each visit.
On some days in the first few weeks of treatment, the trial team will take a number of extra blood and urine samples both before and after you take AZD1208.These samples will help them to see how your body absorbs the drug and how it gets rid of it. This is called
The researchers will ask you to have a
They will also ask you to have more biopsies and blood tests during the trial to look for substances called
You don’t have to have these extra blood tests and biopsies for pharmacodynamics or biomarker research if you don’t want to. You can still take part in the trial.
When you finish treatment, you see the trial team again and have a physical examination, blood tests, ECGs and a CT, MRI or PET scan. If you have lymphoma, you may also have a bone marrow test.
A member of the trial team will phone you 4 weeks later to see how you are.
This is the first time that AZD1208 is being tested in people with solid tumours or lymphomas, so there may be some side effects we don’t know about yet. Possible side effects include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Being sick
- Changes to the way your
thyroid glandworks causing weight loss and sweating
- Change to your heart rate
- Changes to the way your liver and kidneys work
- Swelling (inflammation) of your lungs which could cause breathlessness
In men, AZD1208 may cause changes to the testicles that could lead to
How to join a clinical trial
Professor Johann de Bono
Professor Malcolm Ranson
Experimental Cancer Medicine Centre (ECMC)