Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at GSK1120212 and pazopanib with paclitaxel for people with melanoma (PACMEL)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at 2 new drugs called GSK1120212 (also known as trametinib) and pazopanib, with paclitaxel chemotherapy for people with advanced melanoma.
More about this trial
Trametinib is a type of biological therapy called a
In this trial doctors want to combine trametinib or pazopanib with paclitaxel chemotherapy to see if this works better than paclitaxel alone. The trial is divided into 2 parts, or phases. Phase 1, which is now complete, looked at the best dose of trametinib to give. Researchers are now recruiting people to join phase 2, which will look at paclitaxel on its own, or with trametinib or pazopanib.
If you join the trial you will have your cancer tested to see if it has a change to a
The aims of this trial are to find out
- The best dose of trametinib to give in combination with paclitaxel (phase 1)
- If trametinib or pazopanib with paclitaxel work better than paclitaxel alone in people whose melanoma cells don’t have a change (mutation) in a gene called BRAF (phase 2)
- About the side effects
Who can enter
The first part of this trial (phase 1) is now complete. You may be able to enter the second part (phase 2) of this trial if you
- Have stage 3 or 4 melanoma that can’t be removed with surgery
- Have melanoma cells that don't have a change (mutation) in a gene called BRAF
- Have melanoma that can be measured on a CT scan
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Have a liver that is working properly
- Are able to swallow tablets
- Are willing to use reliable contraception during treatment if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have melanoma of the eye or moist tissues lining body cavities (
- Have had any other treatment that reaches your whole body (
systemic treatment) in the last 28 days
- Have had any
taxanechemotherapy, BRAF or MEK inhibitors in the past (your doctor can explain this)
- Have any side effects from previous treatment that are still causing you problems
- Have certain heart problems
- Have any other medical problem that is a cause for concern
- Have had radiotherapy in the last 2 weeks
- Have had any other cancer in the last 3 years
- Have melanoma that has spread to your brain unless it has been treated and has not caused any problems in the last 3 months
- Are allergic to paclitaxel
- Have had any major surgery or injury in the last 28 days
- Are HIV positive
- Are hepatitis B or C positive
- Are pregnant or breastfeeding
This is a phase 1/2 trial.
In phase 1, the researchers found the best dose of trametinib to give in combination with paclitaxel.
Phase 2 is randomised. The people taking part are put into 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- Group 1 have paclitaxel and the best dose of trametinib found in phase 1
- Group 2 have paclitaxel with pazopanib
- Group 3 have paclitaxel on its own
Everyone in the trial has paclitaxel through a drip into a vein every week for 3 weeks then a week with no treatment. Each 4 week period is called a cycle of treatment. You have up to 6 cycles of paclitaxel.
People in groups 1 and 2 take trametinib tablets or pazopanib tablets daily. You can take these for as long as they are helping you, even after you have finished paclitaxel. If your cancer starts to grow then you stop treatment.
You see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Heart trace (
- Heart ultrasound (
- Eye test
- Urine test
- CT scan or MRI scan
- Pregnancy test
The researchers also need to check your melanoma cells for gene changes. They may be able to use a sample that was collected in the past, but if not, you will need to have a
While you have paclitaxel you have frequent physical examinations, blood and urine tests. You have them again 30 days after you finish paclitaxel.
While you have treatment with paclitaxel you have a CT scan every 8 weeks. After you finish paclitaxel treatment you have CT scans every 3 months until your cancer starts to grow again.
If you continue to take trametinib or pazopanib after you finish paclitaxel, you will have physical examinations, blood and urine tests every month. You also have heart tests and CT scans every 3 months until you stop treatment.
The most common side effects of paclitaxel are
- Hair loss
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Tiredness (fatigue)
- Sore mouth
- Altered taste
- Aching joints – for a couple of days only
The most common side effects of trametinib are
The most common side effects of pazopanib include
- High blood pressure
- Feeling or being sick
- Tiredness (fatigue)
- Skin rash
- Short term changes to the way your liver,
bone marrowand thyroidwork
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 Mark Middleton
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Oxford
This is Cancer Research UK trial number CRUKE/11/033.