A trial of CCS1477 for prostate cancer and other solid tumours

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 hormone treatment .
• You have had abiraterone and or enzalutamide. 
• You have had a chemotherapy drug such as docetaxel
• Your PSA levels  and 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. 

Cancer related 
You: 

• 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 immunotherapy  you 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 cancer  or carcinoma insitu (CIS ) that has been successfully treated 

Medical conditions
You:

• 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 (peripheral neuropathy )
• 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

Other
You:

• are allergic to any of the trial medications or anything they contain
• are pregnant or breastfeeding