A trial of AZD3965 for advanced cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 1

This trial is looking at a drug called AZD3965. It is for people who have a solid tumour Open a glossary item or a type of lymphoma called:

Diffuse large B cell lymphoma
Burkitt lymphoma

The trial is supported by Cancer Research UK.

More about this trial

Researchers are looking for new drugs to help people who have advanced cancer Open a glossary item 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

Find the highest dose of AZD3965 you can have safely
Learn more about the side effects and what happens to the drug in your body
See what effect AZD3965 has on certain types of cancer

Who can enter

You may be able to enter the trial if

You have a solid tumour or lymphoma
There is a sample of your cancer available from when you had surgery or a biopsy in the past
Your cancer is getting worse despite having other available treatments, or there are no other treatments you can have
You have satisfactory blood test results
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old
You are willing to use 2 forms of contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if you

Have cancer spread in the brain or the membranes that surround the brain (leptomeningeal metastases) and this is causing symptoms
Have had radiotherapy (apart from radiotherapy for symptoms), hormone therapy, immunotherapy , another experimental drug or chemotherapy in the last 4 weeks (6 weeks if you had a drug called mitomycin C or a drug called a nitrosourea )
Have had radiotherapy to more than a quarter of your bone marrow in the last 8 weeks (your doctor can confirm this)
Have not recovered from major surgery to your chest or abdomen
Have not recovered from side effects of other treatment unless they are very mild (apart from hair loss)
Have had a bone marrow transplant using cells from a donor
Are taking part in another clinical trial of an experimental treatment
Have certain eye problems such as a condition called macular degeneration
Have certain heart problems (the trial team will check for these)
Cannot swallow medication, or have problems with your digestive system that could affect how you absorb drugs you take by mouth
Take steroids and have had the dose changed in the last 2 weeks
Have had a serious allergic reaction in the past, or have a disease affecting your immune system called an autoimmune disease
Have diabetes unless it is very well controlled by your diet, insulin or other types of medicines for diabetes
Have a pacemaker
Have an infection or another medical condition that the trial doctors think could affect you taking part
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

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.

Hospital visits

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 (if you haven’t had one in the last 4 weeks)
Heart trace (ECG )
Heart ultrasound (echocardiogram )
Saliva test
2 magnetic resonance spectroscopy (MRS) scans (these are similar to MRI scans and show the activity of your cancer)

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 biopsy Open a glossary item ), 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.

Side effects

As AZD3965 is a new drug, there may be side effects we don’t know about yet. The possible side effects include

Sore mouth
Sores on your genitals
A drop in the number of red blood cells (anaemia )
Sickness

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.