Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial of CCS1477 for prostate cancer and other solid tumours
This trial is for people with a solid tumour that has spread elsewhere in the body. This is advanced cancer or metastatic cancer.
More about this trial
Doctors are looking for new treatments for people with advanced cancer when other treatments have stopped working. In this trial they are looking at a new drug called CCS1477.
CCS1477 is a targeted drug. It stops signals that cancer cells use to divide and grow. Researchers think that it might slow cancer growth. But they aren’t sure so want to find out more.
The researchers plan to look at how CCS1477 works in men who have advanced prostate cancer. And to find out the best dose to have in combination with hormone treatment for prostate cancer. These include abiraterone and enzalutamide.
They are also looking at how CCS1477 works for people with other advanced solid tumours.
The main aims of the trial are to:
- find the best dose of CCS1477
- find out what happens to CCS1477 in the body
- look at having CCS1477 with abiraterone or enzalutamide for men with prostate cancer
- find out how well CCS1477 works
Who can enter
The following bullet points list 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.
There are 5 main treatment groups in this trial. Groups A, B, C and D are for men with prostate cancer. And group E is for people with any solid tumour.
Who can take part
To join group A, B, C or D the following must apply.
- You have prostate cancer that has spread elsewhere in the body despite having
- You have had abiraterone and or enzalutamide.
- You have had a chemotherapy drug such as docetaxel
PSA levelsand or scans show that your cancer is getting worse.
- The amount of PSA in your blood when you join the trial is more than 2ng/dl.
- You have very low levels of
testosterone(less than 50 ng/dL).
To join group E the following must apply. You:
- have a solid tumour that has spread elsewhere in the body and there is no other suitable treatment available
- have certain genetic changes (
mutations) on your cancer cells (the trial team check this with a tissue or blood sample)
As well as the above entry conditions for each group, the following must apply for all the groups. You:
- have a cancer that your doctors can see on a scan
- have satisfactory blood test results
- are well enough to carry out all your normal activities but might not be able to do heavy physical work (performance status of 0 or 1)
- are willing to use reliable contraception during treatment and for 3 months afterwards if you or your partner could become pregnant. You are willing to use a condom during treatment and for 1 week after if you are a man and can pass your sperm to another person
- are at least 18 years old
Who can’t take part
You cannot join this trial if any of the following apply. These are the main exclusion conditions.
- have cancer that started in the brain or cancer that has spread to the brain. You might be able to take part if you have had treatment for cancer that has spread to the brain and you haven’t had symptoms in the 28 days before starting the trial drug.
- have had chemotherapy, an anti cancer drug, or an experimental treatment in the last 14 days or a treatment that hasn’t completely cleared your body. This does not apply to abiraterone or enzalutamide. The team decide about any
immunotherapyyou may have had on a case by case basis
- have had radiotherapy to more than 30% of the bone marrow within 4 weeks of trial treatment
- have had another cancer in the past apart from
non melanoma skin canceror carcinoma insitu ( CIS) that has been successfully treated
- have had major surgery or a very bad injury within 4 weeks of trial treatment or you might need major surgery
- take medication for high cholesterol (statins) that you can’t stop taking. You should never stop taking a medication without first talking to your doctor.
- have side effects from past treatments that aren’t getting better unless they are mild apart from hair loss or numbness and tingling in the hands or feet (
- have an active infection including hepatitis B, hepatitis C or HIV
- have congestive heart failure that is causing problems, high blood pressure that isn’t well controlled with medication, angina that isn’t well controlled with medication or an abnormal heart rhythm
- have a heart condition called a QT prolongation
- have a medical condition that means you are more likely to have a bleed
- have taken any medication that blocks an enzyme called CYP3A4 in the 4 weeks before joining this trial
- have taken a herbal medicine in the 7 days before starting trial treatment or you have taken St John’s wort in the last month
- have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
- are allergic to any of the trial medications or anything they contain
- are pregnant or breastfeeding
This is a phase 1/2 trial. The researchers need 250 people from the UK and the US to take part. This includes 180 from the UK.
There are 5 treatment groups in this trial. Which treatment group you are in depends on your cancer type and the entry conditions of the trial.
CCS1477 is a capsule. The team tell you how many to take. You take them in the morning with a glass of water. You must fast (water only) for at least 2 hours before taking your trial medications and for at least 1 hour after.
Everyone has treatment for as long as it is working, and the side effects aren’t too bad.
|Group A||finding the best dose of CCS1477 in men with prostate cancer|
|Group B||testing the best dose CCS1477 in more men with prostate cancer|
|Group C||looking at the combination of CCS1477 and abiraterone for men with prostate cancer|
|Group D||looking at the combination of CCS1477 and enzalutamide for men with prostate cancer|
|Group E||looking at the best dose of CCS1477 in people with any solid tumour|
Group A is for men with prostate cancer. The first few men have a low dose of CCS1477. If they don’t have bad side effects, the next few have a higher dose. And so on until they find the best dose. This is a dose escalation study.
Group B is for men with prostate cancer. When they find the best dose of CCS1477 in group A then group B can open.
The researchers are looking at 2 different doses and or schedules in a larger group of men.
The team tell you how often to take CCS1477 and how many to take.
The researchers might ask you to join an extra part of the trial. This is looking at what happens to CCS1477 in the body if you take it with or without food. The team let you know if you will be involved in this research.
Group C is for men with prostate cancer. In this group you have CCS1477 and a prostate cancer drug called abiraterone. It is a hormone therapy drug.
There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have alongside abiraterone. Part 2 is testing this dose level and combination in a larger group of men.
Abiraterone is a tablet. You take them at the same time as you take CCS1477. The team let you know how much CCS1477 to take and how often to take it.
Everyone in group C also takes a steroid drug called prednisolone.
This group is for men with prostate cancer. In this group you have CCS1477 and a prostate cancer drug called enzalutamide. It is a hormone therapy drug.
There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have alongside enzalutamide. Part 2 is testing this dose level and combination in a larger group of men.
Enzalutamide is a capsule. You take them once a day, everyday. You have them at the same time as you take CCS1477. The team let you know how much CCS1477 to take and how often to take it.
This group is for people who have any solid tumour.
There are 2 parts. Part 1 is looking at the best dose of CCS1477 to have. Part 2 is testing this dose in more people.
CCS1477 is a capsule. The team let you know how much CCS1477 to take and how often to take it.
You see a doctor and have some tests before you can take part in the trial. These include:
For those with a solid tumour, the researchers do some tests to look for specific gene changes in your cancer cells. They use a tissue sample (
Everyone has regular check ups during treatment. The team can tell you more about how often these happen.
At some visits you might need to stay overnight at the hospital or at a nearby hotel and return to the hospital in the morning.
You have a CT scan or MRI scan every:
- 2 months for 6 months
- 3 months after that
You see the trial team one month after you stop treatment for a check up.
Samples for research
The team ask for a sample of tissue from a previous surgery or biopsy. Some people in the trial need to give 3 extra tumour samples. The team tell you if this applies to you.
Everyone also gives some extra blood samples. Where possible you give these at the same time as your routine blood samples.
The researchers plan to use the samples to:
- look for
- find out what happens to the drug in the body (
- find out more about how treatment works
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.
CCS1477 is a new drug so there might be some side effects that the researchers don’t know about yet.
So far the most common reported side effects in people with solid tumours include:
- a drop in the number of blood cells causing an increased risk of bruising and bleeding and breathlessness
- low levels of sodium in your blood
- feeling or being sick
CCS1477 can make you more sensitive to sunlight. You should avoid going out in the sun for long periods during treatment and for 4 weeks afterwards. You should cover up and try to stay in the shade. The team advise you to apply a sunscreen that is SP30 or higher.
You should not take any herbal medication during treatment. Nor should you have large amounts of grapefruit or Seville oranges. These can interfere with how treatment works.
The most common side effects of abiraterone include:
- swelling of legs or feet
- urine infections
- high blood pressure
- low levels of potassium in your blood
The most common side effects of enzalutamide include:
- hot flushes or sweats
- high blood pressure
We have more information about:
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.
Professor Johann De Bono