
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.
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 AZD6738 for people who have an advanced solid tumour. A is any type of cancer apart from leukaemia or
. The trial is supported by Cancer Research UK.
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. This part of the trial is now closed. 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
Part 1 of the trial is now closed. You might be able to enter the 2nd part of the trial if all of the following apply.
You cannot join this trial if any of these apply.
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.
Part 1 of the trial is now closed. In this part of the trial, doctors looked at the highest safe dose of AZD6738. The first few patients had the lowest dose. If they didn't have any serious side effects, the next patients had a higher dose. And so on, until they found 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.
You 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 () and to look for substances called
to find out why treatment might work for some people and not for others.
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
You go to hospital to have your first dose of AZD6378. Everybody will need to go to hospital regularly during treatment. During your hospital visits you 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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Kevin Harrington
AstraZeneca
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.
Freephone 0808 800 4040
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.