Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at AZD6738 with radiotherapy for advanced solid tumours (PATRIOT)
This trial is looking at a new drug called AZD6738 for people who have an advanced solid tumour. A
AZD6738 is a type of biological therapy. It works by blocking messages that signal cancer cells to repair damaged DNA. In this trial, the researchers are collecting information about how well AZD6738 works and how safe it is for people with solid tumours. This is the first time that it has been tested in people who have solid tumours.
The trial is in 3 parts. In part 1 the researchers are looking at the best dose of AZD6738 to give. In part 2 they are looking at how often to give it. And in part 3 they are looking at AZD6738 alongside radiotherapy to control symptoms.
The aims of the trial are to
- Find the best dose of AZD6738
- Learn more about the side effects and see what happens to AZD6738 in the body
- Find the best treatment plan
- See if AZD6738 can help people with solid tumours
- Find out if AZD6738 helps radiotherapy to control symptoms work better
Who can enter
You may be able to enter the 1st or 2nd part of the trial if all of the following apply.
- You have an advanced
solid tumour(not a lymphomaor leukaemia) that has got worse despite having other treatment, or there is no other treatment that you can have
- Your cancer can be measured on a scan
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are at least 18 years old
- You are willing to use reliable contraception if there is any chance you or your partner could become pregnant
As well as the above, to join the 2nd part of the trial, the p53 gene has to be damaged or missing from your cancer cells (the trial team can tell you more about this)
You cannot join this trial if any of these apply.
- You have cancer that has spread to your brain or spinal cord and is getting worse or is causing symptoms
- You have had chemotherapy, hormone therapy or biological therapy in the last 4 weeks (6 weeks if you had chemotherapy drugs called
nitrosoureasor a drug called mitomycin C)
- You have had major surgery in the last 2 weeks
- You haven’t recovered from the side effects of earlier treatment, unless they are very mild
- You are taking part in another clinical trial of an experimental drug
- You have any problems with your
digestive systemthat could affect how you swallow or absorb the trial drug
- You have a significant heart problem
- Your blood pressure isn’t well controlled with medication
- You take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
- You have a bad infection that cannot be controlled with medication
- You have a serious problem with your liver or kidneys
- You are known to be allergic to any of the drugs in the trial
- You are known to be HIV, hepatitis B or hepatitis C positive
- You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- You are pregnant or breastfeeding
To join the 3rd part of the trial, all of the above must apply, but also, you must be going to have a short course of radiotherapy to control symptoms. You cannot take part if you have had radiotherapy for these symptoms in the past.
This is a phase 1 trial. The researchers need up to 150 people to take part. There are 3 parts to this trial. Everybody will take AZD6378 tablets twice day.
In the 1st part, doctors are trying to find the highest safe dose of AZD6738. The first few patients taking part will have the lowest dose. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
In the 2nd part of the trial, doctors are trying to find the best treatment plan for AZD6738. So you may have AZD6738 for 3 weeks and then not have it for a week. Or you may have it for 5 days and then not have it for 2. Everybody joining this part will have the highest safe dose that is found in part 1.
If you join part 1 or part 2, you can have treatment for as long as it is helping you, as long as you don’t have bad side effects.
There will be a third part to this trial. This is for people who are going to have radiotherapy to control symptoms. In this part, you have a slightly lower dose of AZD6738 than the people in part 1. The doctors want to find out if AZD6738 helps radiotherapy for cancer symptoms to work better.
You have radiotherapy everyday from Monday to Friday for 2 to 3 weeks. You start having AZD6738 a day or 2 before you start radiotherapy. You may stop AZD6738 when you finish radiotherapy. Or you may continue to take it as long as it is helping you.
You have extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The researchers want to find out what happens to AZD6738 in the body (
The researchers will also ask to take biopsies of your cancer at the beginning and once during treatment. They will also look for biomarkers and they may use it for other tests in the future.
You see the trial doctors and have some tests before you start the trial drug. The tests include
- Physical examination
- Blood tests and urine tests
- CT scan or MRI scan
- Heart trace (
- Heart ultrasound (
You go to hospital to have your first dose of AZD6378. Everybody will need to go to hospital regularly during treatment. For people in part 1, this includes some overnight stays when you start treatment to have blood tests at different times during the day. During your hospital visits you also have a physical examination and blood and urine tests.
As long as you are not having any bad side effects, after the first 4 weeks of treatment, you reduce your hospital visits to once every 2 weeks.
The people in part 3 go to the hospital every day (Monday to Friday) for radiotherapy for up to 3 weeks.
Everybody taking part in the trial will have a heart ultrasound (echocardiogram) every 4 weeks and a CT scan every 8 weeks.
When you finish taking AZD6378 you see the trial team for a check up every week or 2 until you have recovered from any treatment side effects. After that you see them every 3 months for up to a year.
AZD6738 is a new drug and this is the first time that it has been tested in people with solid tumours. We don’t know much about the side effects yet.
One of the possible side effects is a drop in white blood cells causing an increased risk of infection.
The trial team will monitor you closely. When they know more about the side effects they will let you know.
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 Kevin Harrington
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden NHS Foundation Trust
This is Cancer Research UK trial number CRUKD/14/007.