
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial is looking at a new drug called MDX-124 for solid tumours that have grown into surrounding tissues or spread elsewhere in the body.
A solid tumour is any type of cancer apart from blood cancers such as and
.
Cancer that has spread is .
for solid tumours include surgery, chemotherapy and radiotherapy. Sometimes cancer comes back after treatment. So doctors are looking for new treatments to give when standard treatments have stopped working for advanced cancer.
In this trial they are looking at a drug called MDX-124. It is a type of called a
. It targets a protein called ANXA1 that is found in higher than normal levels in many solid tumours. MDX-124 attaches to ANXA1 and stops the signals that cancer cells use to divide, grow and spread. It also helps the
to find and kill cancer cells.
There are 2 parts to this trial. In the first part, the team are looking at the best dose of MDX-124 to give. In the second part they are testing this dose in combination with chemotherapy for people who have pancreatic cancer.
The main aims of the trial are to:
The following bullet points are a summary of the main entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join part 1 of the trial if all of the following apply. You:
You may be able to join part 2 if all of the following apply. You:
As well as the entry conditions above, all of the following must apply. You:
Who can’t take part
You cannot join this trial if any of these main exclusion conditions apply.
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
As well as the above there are specific exclusion criteria for each treatment group. Speak to your doctor or research nurse if you want to find out more about the entry conditions for this trial. |
This is a phase 1 trial. It is taking place in the UK. The team need up to 74 people to take part.
The trial has 2 parts:
Part one
The team need about 44 people to join part one. The first few people taking part have a low dose of MDX-124. The next few people have a higher dose if they don’t have any serious side effects. And so on, until doctors find the best dose. This dose is one that helps the most and has the fewest side effects. Once they find this dose, they test it in a few more people.
Part two
The researchers need up to 30 people with pancreatic cancer to join this part. This part is not open to recruitment yet. It will open when they find the best dose in part 1. In this part you have MDX-124 alongside chemotherapy.
How you have treatment
Everyone has MDX-124 as a drip into a vein. It takes about 30 minutes each time.
Everyone has MDX-124 once every 2 weeks.
Those having gemcitabine and nab-paclitaxel have it once a week for 3 weeks. You then have a week when you don’t have chemotherapy.
You have treatment for about 7 months. You may have it for longer if treatment is still working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about this.
Samples for research
The researchers might ask you to give an extra tissue sample. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
They plan to use the samples to:
You don’t have to agree to give the extra tissue sample if you don’t want to. It won’t affect you taking part in the rest of the trial. You don’t have to give all the blood samples for research either.
You see the doctor and have tests before you can take part. These include:
You have all your treatment at the hospital. You have a number of hospital visits in the first week of treatment. After that you have regular blood tests and check ups with your doctor.
You have a CT or MRI scan at:
You stop the trial scans if your cancer gets worse.
You see the trial team one month after you finish treatment. They then call you every 3 months or they may see you at a routine hospital appointment. This is to see how you are getting on.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
This is the first time people are having MDX-124. So there may be side effects we don’t know about yet.
MDX-124 can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
The most common side effects of drugs that work in a similar way to MDX-124 include:
Other possible side effects of drugs similar to MDX-124 include:
We have information about gemcitabine and nab-paclitaxel and its side effects.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Daniel Palmer
Liverpool Cancer Trials Unit
Medannex Limited
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”