A trial looking at CCT3833 for people with solid tumours and melanoma (panRAF)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

All cancer types
Melanoma
Secondary cancers
Skin cancer

Status:

Closed

Phase:

Phase 1/2
This trial is for people with a solid tumour or melanoma skin cancer that has spread to other parts of the body (advanced cancer). 
 
This trial is in 2 parts. Part A is for people with advanced solid tumours. A solid tumour Open a glossary item is any type of cancer that is not a blood or lymphatic system cancer. These include:
  • leukaemia Open a glossary item
  • myeloma Open a glossary item
  • lymphoma Open a glossary item
Part B is for people with advanced melanoma.

More about this trial

CCT3833 is a new targeted cancer drug. It works by blocking the proteins BRAF and CRAF. Cells Open a glossary item need these to grow and divide. Drugs that can block these proteins are called panRAF inhibitors.  
 
Researchers think that CCT3833 may be able to block these proteins and stop cancer cells growing and dividing. This trial will be the first time people will have CCT3833. 
 
In part A of this trial, researchers want to find the best dose of CCT3833. This is called dose escalation. Once researchers find the best dose, they will start part B. This part is called the expansion cohort.
 
The main aims of this trial are to:
  • find the highest safe dose of CCT3833
  • learn about the side effects of CCT3833
  • find out what happens to the drug in the body (pharmacokinetics Open a glossary item) and the effects it has (pharmacodynamics Open a glossary item)
  • look for new biomarkers Open a glossary item that can tell how well treatment work

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. 
 
You may be able to join this trial if all of the following apply. You:
  • have satisfactory blood tests results
  • are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • are able to swallow and absorb capsules
  • are at least 18 years old
  • are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility you or your partner could become pregnant
You may be able to join part A of this trial if you have a solid tumour (not a leukaemia, myeloma or lymphoma) that has spread to other parts of the body.
 
You may be able to join part B of this trial if all of the following also apply:
  • you have melanoma that has spread to other parts of the body and doctors think you can’t have surgery to remove it
  • your cancer has a change (mutation Open a glossary item) on the BRAF or RAS gene (your doctor will check for this)
  • you have at least 1 area of cancer that can be seen and measured on a scan
You cannot join this trial if any of these apply:
 
Cancer related
  • you have had treatment with immunotherapy Open a glossary item or chemotherapy in the past month (6 weeks if you had the drug mitomycin C or chemotherapy from a group of drugs called nitrosoureas Open a glossary item)
  • you have had an experimental treatment as part of another clinical trial in the past 4 weeks
  • you have had radiotherapy in the last month, unless it was to control symptoms (palliative radiotherapy)
  • you have had treatment that blocks or lowers the amount of hormones in the body (endocrine therapy), apart from drugs that stop the production of luteinising hormone Open a glossary item such as Zoladex
  • your cancer has spread to your brain unless it has been stable for more than 3 months and you don’t need steroids or drugs to prevent fits (seizures) 
Medical conditions
  • you have had a major surgery in the last 4 weeks
  • you have heart problems such as congestive heart failure, an irregular heartbeat (arrhythmia), high blood pressure that is not controlled by medication, angina that is not controlled or you have had a heart attack in the past year
  • you have taken drugs that affect some enzymes called CYP3A4 and CYP2C8 in the last 2 weeks (your doctor will check for this)
  • you have an infection that needs treatment
  • you take warfarin
  • you have HIV
  • you have hepatitis B or hepatitis C
  • you are sensitive to CCT3833 or anything it contains
  • you have any other serious medical condition that the trial team think could affect you taking part
Other
  • you are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. Researchers would like about 69 people across the UK to take part. This trial has 2 parts:
  • dose escalation (part A)
  • expansion cohort (part B)
Everyone has CCT3833. These are capsules you take every day, with food. The dose you have depends on the part of the trial you join. 
 
Part A  
Researchers need 42 people with any type of advanced cancer to join this part. 
 
The first few people taking part will have a low dose of CCT3833. If they don’t have any serious side effects, the next few people have a higher dose. And so on, until doctors find the best dose. 
 
The first time you take CCT3833 you stay in hospital or nearby for a night. This is so doctors can check how you are. 
 
You continue to have treatment for as long as the trial doctor thinks it is helping you and the side effects aren’t too bad. 
 
Part B
The researchers hope that around 27 people with advanced melanoma will take part. Everyone has the highest safe dose found in part A.
 
You continue to have treatment for as long as your doctor thinks it is helping you and the side effects aren’t too bad. 
 
Blood tests
You have extra blood tests before you start treatment and then at set times during the trial. Researchers want to:
  • find out what happens to CCT3833 in the body
  • look for cancer cells DNA Open a glossary item in your bloodstream (circulating tumour DNA)
  • see if CCT3833 can affect normal cells
You don’t have to agree to the extra blood tests if you don’t want to. You can still take part in this trial.
 
Tissue sample 
Researchers may ask you to have a tissue sample taken (a biopsy Open a glossary item). They want to find out how CCT3833 affects the cancer.
 
You have a biopsy before, during and at the end of treatment. You don’t have to agree to this if you don’t want to. You can still take part in this trial.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:
  • a physical examination
  • heart trace (ECG Open a glossary item)
  • heart ultrasound (echocardiogram Open a glossary item)
  • blood tests
  • urine tests
  • a CT scan 
You may need to stay in hospital for 1 night after having the first dose of CCT3833. You should not need to stay in hospital again. You have the rest of your treatment as an outpatient. 
 
During treatment, you see the trial doctor every week for the first 2 months. This is for blood tests, a physical examination and a heart trace (ECG). After this you see the trial doctor every 2 weeks. 
 
You have a CT scan every 8 weeks while you are having treatment. This continues for as long as your cancer stays the same and does not get worse. You stop treatment if your cancer gets worse. 
 
When you finish treatment, you see the trial team every month until all side effects disappear. You then see or speak with the trial team every year.

Side effects

This is the first time people have taken CCT3833 so doctors aren’t sure what the possible side effect are yet. 

The trial team monitor you while you are having treatment and between treatments. They will give you a phone number to call them if you are worried about anything. 

The trial team will let you know about the possible side effects as they find out about them.

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 James Larkin

Supported by

Institute of Cancer Research (ICR)
NIHR Biomedical Research Centre
The Royal Marsden NHS Foundation Trust 

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9555

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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