"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at saracatinib for pain caused by cancer spread to the bone (SarCaBon)
This trial is to see if a drug called saracatinib can reduce pain caused by cancer that has spread to the bones.
More about this trial
Cancer sometimes spreads from the place where it started to the bones. You may hear this called secondary bone cancer or bone metastases. Secondary bone cancer can make the bones break down and cause pain. The type of pain caused by secondary bone cancer can be difficult to control.
A molecule called Src may be involved with bone pain caused by cancer. This trial is testing a drug called saracatinib which targets Src. The researchers want to see if it can reduce pain caused by secondary bone cancer more than a dummy drug (a
The aims of the trial are to
- See if the pain that people report is less with saracatinib than with the dummy drug
- Find out if people take fewer painkillers with saracatinib than with the dummy drug
- See if symptoms related to pain and
quality of lifeimprove with saracatinib
- Find out if saracatinib affects the rate at which cancer breaks down bone
Who can enter
You may be able to join this trial if all of the following apply. You
- Have a
solid tumouror myelomathat involves your bones (a solid tumour is any cancer apart from leukaemiaor lymphoma)
- Have bone pain that is difficult to control despite having strong painkillers such as morphine
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Score between 2 and 9 on a scale of 0 to 10 when your pain is assessed on 2 separate days using a questionnaire called the Brief Pain Inventory (BPI)
- Have satisfactory blood test results
- Are at least 16 years old
- Are able to swallow and absorb tablets
- Are willing to use reliable contraception during the trial and for up to 3 months afterwards if there is any chance you or your partner could become pregnant
You cannot join this trial if any of these apply. You
- Have had radiotherapy to the area of bone that is painful in the last month (or this type of treatment is planned for you in the next month)
- Are having chemotherapy unless it is a low dose that you have been having for more than 6 weeks (maintenance therapy) and is not part of a clinical trial
- Have certain heart or lung problems (the trial team can advise you about this)
- Need to take any other medication that can affect a body substance called CYP3A4 (your doctor can advise you about this)
- Are pregnant
- Can’t understand written or spoken English
This phase 2 trial aims to recruit 24 people. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
People in one group take saracatinib tablets once a day for 4 weeks. People in the other group take dummy drugs (
Before you start the treatment, the trial team will ask you to fill out 3 short questionnaires about your pain and your
The trial team will ask you to complete the questionnaires again
- On the day you start taking the trial tablets
- After 2 weeks of taking them
- After 4 weeks of taking them
They will also ask you to keep a diary for a week before you start the tablets. In this, you write down details about your pain and any medication you take. You can carry on taking all your usual painkillers.
They will ask you to fill in your pain diary again during the 2nd and 4th weeks of taking the tablets.
You see the trial team and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- Urine test
- Heart trace (
The trial team will ask you about all the other medicines you take and they will do some simple tests to see how sensitive you are to pain. They test sensations on your skin using gentle brushing, warm and cool touch. They also do mildly uncomfortable tests using pressure, heat and cold.
You then see the trial team 3 more times
- At the beginning of treatment
- After 2 weeks of treatment
- After 4 weeks of treatment
Each visit will last 2 to 3 hours.
If at the end of the trial you have had a certain amount of improvement in your pain, it may be possible for you to continue with the study drug for another 6 months. If this happens you will have regular visits to the hospital so the trial team can monitor you for any side effects.
As saracatinib is quite a new drug, there may be side effects we don’t know about yet. In other trials, the most common side effects have been
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Andrew
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield