A trial of EMD 525797 for bowel or ovarian cancer that has spread to the liver

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

Cancer type:

Bowel (colorectal) cancer

Colon cancer

Ovarian cancer

Rectal cancer

Status:

Closed

Phase:

Phase 1

This trial is looking at a new drug called EMD 525797 for bowel cancer and ovarian cancer. It is for people whose cancer has spread to their liver and has got worse despite having other standard treatments Open a glossary item .

Doctors use treatments such as surgery and chemotherapy for bowel or ovarian cancer. But sometimes the cancer spreads to the liver. Researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a drug called EMD 525797.

EMD 525797 is a type of biological therapy called a monoclonal antibody. It attaches to proteins called integrin receptors Open a glossary item found on some cancer cells and blood vessels. EMD525797 blocks integrin receptors and can stop cancer cells growing, spreading and developing their own blood supply (angiogenesis ).

Doctors will use a type of MRI scan called a dynamic contrast enhanced MRI (DCE-MRI) to see how the drug affects blood vessels in the cancer. The aims of the trial are to

Find the highest dose of EMD 525797 that you can have safely
Learn more about how the drug works and what happens to it in your body

Who can enter

You may be able to enter this trial if you

Have bowel cancer or ovarian cancer that has spread to your liver and has got worse despite having standard treatment
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 willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have cancer that has spread to your brain
Have already had a drug that blocks integrin receptors (your doctor can advise you about this)
Have had another drug that blocks blood vessel growth (an anti angiogenic drug) in the last 6 months
Have had an allergic reaction to another monoclonal antibody
Have had any other cancer treatment, or an experimental drug as part of another trial in the last 30 days
Have had a biopsy in the last 2 weeks
Have taken drugs to thin your blood (anti coagulants) such as warfarin in the last 10 days
Take aspirin tablets each day, unless it is a low dose – the trial team can advise you about this
Have problems with bleeding or have ever had a blood clot
Have high blood pressure that cannot be controlled with medication
Have severe narrowing of the blood vessels in your legs (peripheral vascular disease) or leg ulcers
Have had a heart attack in the last 6 months or have any other heart condition that is a cause for concern
Have an infection that cannot be controlled with medication
Have any other medical condition or mental health problem that the trial doctors think could affect you taking part
Are known to be HIV, hepatitis B or hepatitis C positive
Cannot have MRI scans, for example because you have some metal in your body or you have a pacemaker
Are pregnant or breastfeeding

Trial design

This is a phase 1 trial that will treat about 40 people in Europe.

Everybody taking part will have EMD 252797. You have it through a drip into a vein once every 2 weeks. It takes about an hour each time.

The first few patients taking part will have a low dose of EMD 252797. 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.

As long as you don’t have bad side effects, you can carry on having EMD 525797 for as long as it is helping you.

During the trial, you have up 10 DCE-MRI scans to see how the drug affects blood vessels in your cancer. You also have regular blood tests.

The researchers will use some of the blood samples to learn more about what happens to EMD 252797 in your body, how it affects cancer cells and whether your immune system reacts against the drug. They will also look for substances called biomarkers Open a glossary item that help them to see how well the drug is working.

The trial team will get a sample of your cancer that was removed when you were first diagnosed. Researchers will study this sample to see if contains integrin receptors and other proteins.

Hospital visits

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

Physical examination
CT scan
2 DCE-MRI scans
Heart trace (ECG )
Blood and urine tests

The first time you have EMD 525797, you will be at hospital for at least 4 hours. You then have 4 more hospital visits that week. They won’t last as long as the first day, but you have DCE-MRI scans during 3 of them.

Each DCE-MRI scan takes about 40 to 50 minutes. On the days you have these scans, you cannot drink anything that contains caffeine beforehand.

When you have your next treatment 2 weeks later, you have the same number of hospital visits, but you only have a scan on the day you have EMD 525797. After that, you go to hospital once every 2 weeks for as long as you have the trial treatment.

You have regular blood tests throughout your treatment and more ECGs. You have a CT scan every 6 weeks for the first 6 months and then every 12 weeks until you stop having EMD 525797.

When you finish treatment, you see the trial team 4 weeks later. Depending on how many weeks of treatment you’ve had, you may have another DCE-MRI scan.