A trial of AZD1208 for solid tumours and lymphoma

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

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1

A trial looking at AZD1208 for solid tumours Open a glossary item and lymphomas that have continued to grow despite having other treatment, or for which there is no standard treatment available. In this trial, a solid tumour is any cancer other than leukaemia .

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

Have lymphoma or a solid tumour that has got worse despite having other treatments, or there is no other standard treatment available
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 nitrosourea )
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 system that 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

Trial design

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.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Heart traces (ECGs )
Chest X-ray (if needed)

If you have a solid tumour, you also have a CT scan or MRI scan. If you have lymphoma, you may have a PET scan.

You must agree to the researchers getting a sample of your cancer or lymphoma that was removed when you had surgery or a biopsy Open a glossary item in the past.

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 pharmacokinetics Open a glossary item .

The researchers will ask you to have a biopsy Open a glossary item before and after your first dose of AZD1208. They will study the tissue samples to learn more about the effect AZD1208 has on your cancer or lymphoma. This is called pharmacodynamics .

They will also ask you to have more biopsies and blood tests during the trial to look for substances called biomarkers Open a glossary item . A biomarker is something that can be measured to show if the treatment is working.

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.

Side effects

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 gland works 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 infertility Open a glossary item .