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 vemurafenib for cancers with a change to the BRAF gene (VE-BASKET)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
More about this trial
The main aim of this trial is to find out if vemurafenib helps people with other types of cancer when the cells have a specific change to the BRAF gene.
The trial was recruiting people who have bowel cancer that has spread to another part of the body. They had vemurafenib alongside cetuximab which is a drug doctors can already use to treat bowel cancer that has spread. For these people, the aim of the trial was to see how well the combination of drugs works for bowel cancer that has spread. But this part of the trial has closed now.
Who can enter
You may be able to enter this trial if you have a
- Your cancer has got worse despite having other
standard treatmentsor there are no standard treatments available
- Doctors can see and measure your cancer on a scan
Or if you have myeloma, your myeloma cells have the BRAF V600 gene change and
- You have had at least one other type of myeloma treatment that reached your whole body (
- Doctors can measure your myeloma with blood tests or urine tests
- You finished any radiotherapy for bone pain at least 2 weeks ago
- You have more than 1 area of myeloma
And as well as the above, everybody joining the trial must
- Have satisfactory blood test results
- Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have recovered from the side effects of other recent treatment
- Be able to swallow tablets
- Be at least 18 years old
- Be willing to use reliable contraception during the trial and for at least 6 months afterwards if there is any chance they or their partner could become pregnant
You cannot enter this trial if you
- Have melanoma, papillary thyroid cancer,
- Have cancer that is known to have spread to your brain or spinal cord and hasn’t been treated - you may be able to take part if you have cancer that has spread to your brain but it isn’t causing symptoms, you don’t take steroids and there have been no signs of it getting worse for at least 2 months
- Have (or have had) a condition called carcinomatous meningitis where cancer cells have got into the layers of tissue that surround your brain and spine
- Are currently having any other anti cancer treatment
- Have already had a drug that targets proteins called BRAF or MEK – the trial doctor can advise you about this
- Are known to be very sensitive to vemurafenib or a similar drug (if you are in the group of people with advanced bowel cancer, you mustn’t be known to be sensitive to cetuximab either)
- Have any problem with your
digestive systemthat could affect how you absorb drugs
- Have had a stroke, heart attack or other heart problems in the last 6 months
- Have had a blood clot in your lung (pulmonary embolism) in the last month
- Have high blood pressure that can’t be controlled with medication
- Have an irregular heart rhythm – the trial team can confirm this
- Have another cancer that also needs treatment
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
You take vemurafenib tablets each day. The trial team will ask you to keep a diary at home. In this, you note down any days that you don’t take the tablets for any reason.
If you have side effects or you need to have other treatment such as surgery, your trial doctor will talk to you about reducing the dose or stopping the tablets for a while. You can stop taking them for up to 4 weeks and remain in the trial.
As long as you don’t have bad side effects, you can carry on taking vemurafenib for as long as it is helping you.
You see the trial team and have some tests before you start treatment. The tests include
A skin specialist (dermatologist) will examine your skin before you start treatment and again during the trial. If they find any unusual growths on your skin, you may need to have a
You go to hospital after the first 2 weeks of treatment and then every 4 weeks after that. People in the group having vemurafenib and cetuximab go to hospital once a week throughout their treatment.
Everybody has a blood test at each visit, a heart trace at some visits and a CT or MRI scan every 8 weeks. If you have myeloma, you may also need to have more bone marrow tests during the trial.
When you finish treatment, you see the trial team again 4 weeks later and have a physical examination. You have another heart trace and a dermatologist will examine your skin again if this hasn’t been done in the last 3 months. You have a CT scan of your chest within 6 months of finishing vemurafenib.
The trial doctor will check your medical notes to see how you are every 3 months for up to a year.
The most common side effects of vemurafenib are
- Skin changes including rash, itchy, scaly or dry skin, sensitivity to sunlight and skin cancers. Some people have had rare, severe skin reactions
- Loss of appetite
- Taste changes
- Feeling or being sick
- Hair loss
- Aching muscles or joints
- Tiredness (fatigue)
- High temperature (fever)
- Swollen legs
- Damage to your liver
We have more information about vemurafenib.
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 Ian Chau
NIHR Clinical Research Network: Cancer