A trial of CT7001 for triple negative breast cancer (Module 1 Part B)

Cancer type:

Breast cancer
Secondary cancers

Status:

Open
This trial is looking at CT7001 for triple negative breast cancer that has spread to nearby tissue or to another part of the body (advanced cancer).   
 
Triple negative breast cancer are cancers that have no receptors Open a glossary item for the:
  • hormones oestrogen Open a glossary item and progesterone Open a glossary item
  • HER2 protein Open a glossary item

More about this trial

Doctors use chemotherapy to treat advanced triple negative breast cancer (TNBC). But there are few treatments if the cancer continues to get worse during chemotherapy or comes back after chemotherapy.
 
It is these people the trial team are looking at. 
 
Researchers believe that an enzyme Open a glossary item called cyclin dependent kinase 7 plays an important role in TNBC. Early research suggests that blocking this enzyme could help people with TNBC.  
 
CT7001 works by blocking the cyclin dependent kinase 7 enzyme. 
 
The aims of this trial are to find:
  • the best dose of CT7001 to give
  • how safe CT7001 is
  • how acceptable it is 
  • out what happens to CT7001 in the body
  • how effective it is in treating the disease

Who can enter

The following bullet points list the 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 this trial if all of the following apply. You:
  • have triple negative breast cancer that has got worse during chemotherapy or came back after chemotherapy
  • have an area of cancer that can be seen on a scan Open a glossary item and measures at least 10mm across or a lymph node Open a glossary item that is at least 15mm across
  • are able to do everything apart from heavy physical work (performance status 0 or 1)
  • are able to swallow capsules and keep them down
  • have satisfactory blood test results
  • are willing to use reliable contraception during treatment and for up to 6 months after treatment
  • are at least 18 years old
Who can’t take part
 
You cannot join this trial if any of these apply. 
 
Cancer related
You:
  • have spinal cord compression Open a glossary item or cancer spread to the brain unless there are no symptoms, it is stable and you haven’t needed steroids for at least 4 weeks before starting treatment
  • have had chemotherapy within 4 weeks of starting treatment
  • have had a targeted cancer drug or immunotherapy Open a glossary item drug within 6 weeks of starting treatment    
  • still have moderate to severe side effects apart from hair loss, caused by any previous anti cancer treatment
  • have had another cancer in the past 3 years apart from cervical intraepithelial neoplasia (CIN) Open a glossary item and non melanoma skin cancer Open a glossary item
Medical conditions 
You:
 
  • are feeling or being sick and it can’t be controlled 
  • have problems with or have had surgery to your digestive system Open a glossary item
  • have fits (seizures) that can’t be controlled by medication
  • have an active infection that needs a treatment that reaches your whole body (systemic therapy Open a glossary item)
  • have a problem with bleeding
  • have had a kidney transplant
  • have hepatitis B, hepatitis C or HIV
  • have a blood transfusion within 2 weeks of starting treatment
  • are having steroids more than 10mg a day within 2 weeks of starting treatment
  • have had medication including herbal medication that affects the CYP enzymes within 3 weeks of starting treatment
  • have had heart problems such as a heart attack, heart failure, unstable angina within 6 months of starting treatment
  • have a condition where your body breaks down red cells (haemolytic anaemia) 
  • have a condition where your bone marrow Open a glossary item isn’t making blood cells 
  • have any other medical or mental health condition that your doctor or the trial team think could affect you taking part
Other
You:
  • are allergic or sensitive to CT7001 or any of its ingredients
  • have had a live flu vaccine Open a glossary item within 28 days of starting treatment
  • are pregnant or breastfeeding

Trial design

This is an international phase 1/2 trial. It is open in the UK and the USA. The team need up to 50 people in the UK to join. Everyone has CT7001.
 
CT7001 is a capsule. Your doctor will tell you how many you take. You take it once a day on an empty stomach. This means you cannot have any food or drink anything, apart from water, for 2 hours before taking CT7001 or for an hour after taking it.  
 
You take the capsules at home except on the days you go to the hospital. You then take your capsules at the hospital when you see the doctor. 
 
You continue taking CT7001 if it is helping and the side effects aren’t too bad. You can choose to stop taking CT7001 at any time but you need to let your nurse or doctor know.
 
Blood samples
The team will take blood samples each time you visit the hospital during the trial. They will use these to:
  • find out what happens to CT7001 in the body
  • monitor your general health
  • look at how the liver helps breakdown CT7001 in the body 
Tissue samples
The trial team will ask for a small piece of cancer tissue (biopsy Open a glossary item) from when you were first diagnosed if you had surgery or a biopsy done. During the trial they will ask for 3 extra samples of cancer tissue. They will use these samples to find out more about triple negative breast cancer and CT7001. 
 
You don’t have to agree to these tissue samples to take part in the trial.
 
Sub study
As part of the trial you might be asked to take part in a sub study. 
 
You cannot join the sub study if any of the following apply. You:
  • have had a bone marrow transplant form a donor (allogeneic bone marrow transplant Open a glossary item)
  • had a blood transfusion that hasn’t had the white blood cells Open a glossary item taken out within 120 days of having the sample taken for the sub study
In this sub study the team will ask for extra blood samples. They will use these to look at the genes that might help breakdown CT7001 in the body. So they can better understand more about how the dose might affect people and who might benefit most from CT7001. 
 
You don’t have to agree to take part in the sub study. 

Hospital visits

You see the doctor to have some tests before agreeing to take part. These tests include:
During treatment you see the doctor regularly for a physical examination, bloods and heart trace. 
 
You have a CT scan or MRI scan every 8 weeks for a year and then every 12 weeks. 
 
At the end of treatment you see the doctor for the same tests you had at the start. 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse
CT7001 is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far are:
Your doctor or a member of the trial team will talk to you about the possible side effects of CT7001 before you agree to take part. 

Location

Cambridge
Glasgow
London
Manchester
Southampton

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Sacha Howell
Dr Matthew Krebs

Supported by

Carrick Therapeutics

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16181

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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