
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 drug called AZD3965. It is for people who have a or a type of
called:
The trial is supported by Cancer Research UK.
Researchers are looking for new drugs to help people who have that is getting worse despite having treatment. In this trial, they are looking at a drug called AZD3965.
AZD3965 blocks a protein that cancer cells rely on to grow. We know from laboratory research that blocking the protein can cause cancer cells to die. But this trial is the first time AZD3965 has been tested in people.
The aims of the trial are to
You may be able to enter the trial if
You cannot join this trial if you
This phase 1 trial will recruit about 63 people.
Everybody taking part will have AZD3965 as capsules that you swallow. You go to hospital to have your first dose. About a week later, you start taking the capsules daily.
In the first part of the trial, doctors are trying to find the highest safe dose of AZD3965. 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. This part of the study is now closed.
Doctors are looking for people to join the 2nd part of this study. Everybody joining part 2 will have the highest safe dose that is found in part 1. Part 2 is for people with a type of non Hodgkin lymphoma called diffuse large B cell Lymphoma (DLBCL) or Burkitt lymphoma.
Depending on the dose you have, you take AZD3965 capsules once or twice each day. As long as you don’t have bad side effects, you can have treatment for up to 6 months. If the treatment is helping you, the trial doctor may talk to you about having another 6 months.
The researchers will need your permission to get a sample of your cancer that was removed when you had surgery or a biopsy in the past. They will use the sample to look for proteins to help them work out which cancers are more likely to respond to AZD3965.
You see the trial doctors and have some tests before you start the trial drug. The tests include
You may also need to have a chest X-ray.
As AZD3965 can affect your vision, you have a range of eye tests before and during treatment. The trial team will give you more information about the different tests, how often you have them and how long they take.
The researchers might ask to take a small sample of your cancer (a ), but this is optional – you don’t have to agree to this if you don’t want to.
You go to hospital to have your first dose of AZD3965. You have a number of blood tests, saliva tests and heart traces in the 4 hours after you take the drug. The next day you have more blood tests, urine tests and eye tests. You also have a heart trace 24 hours after the first dose of AZD3965.
You may need to stay in hospital overnight. You must not drive for 48 hours after your first dose of AZD3965.
When you start taking AZD3965 each day, you go to hospital once a week for the first 8 weeks. At each visit, you see the trial doctors and have blood tests, urine tests, a saliva test, a heart trace and eye tests.
You also have more MRS scans after 2 days, 1 week and 4 weeks of treatment.
As long as you are not having any bad side effects, after the first 8 weeks of treatment, you reduce your hospital visits to once every 2 weeks for the next month and then once every 4 weeks after that.
During treatment, you have regular eye tests and a CT or MRI scan every 8 weeks.
When you finish treatment, you go back to see the trial team 4 weeks later. As well as having a physical examination, you have more blood tests, urine tests, a heart trace, a saliva test, eye tests and a CT or MRI scan.
If your cancer stops growing during the trial and then starts to grow again later on, the researchers may ask you to have another biopsy after you finish treatment. You don’t have to agree to this if you don’t want to.
As AZD3965 is a new drug, there may be side effects we don’t know about yet. The possible side effects include
AZD3965 can cause changes to your heart. You have regular heart traces (ECGs) and blood tests to monitor this.
In men, AZD3965 can affect your testicles and your ability to produce sperm. This can cause pain or discomfort but is likely to return to normal when you stop taking the drug.
AZD3965 may also affect your vision. You have regular eye tests to check this. If you notice any changes in your vision, you should tell your study doctor immediately and you should not drive.
If you do have side effects, you may need to stop taking AZD3965. It might be possible to start taking it again when the side effects have got better. If you can start taking the drug again, the trial team may reduce the dose you have.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Ruth Plummer
AstraZeneca
Cancer Research UK (Centre for Drug Development)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUKD/12/004.
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.