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.

Cancer type:

Skin cancer




Phase 1/2

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

Doctors can use paclitaxel chemotherapy to treat advanced melanoma but it doesn’t always work very well.

Trametinib is a type of biological therapy called a MEK inhibitor Open a glossary item. MEK is a body protein that sends signals to cells telling them to divide and grow. Blocking MEK may also stop cancer cells growing.

Pazopanib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

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 gene Open a glossary item called BRAF. This is called a gene mutation Open a glossary item.

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 (mucosal melanoma Open a glossary item)
  • Have had any other treatment that reaches your whole body (systemic treatment Open a glossary item) in the last 28 days
  • Have had any taxane Open a glossary item chemotherapy, 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

Trial design

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.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

  • Blood tests
  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Heart ultrasound (echocardiogram Open a glossary item)
  • 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 biopsy Open a glossary item.

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.

Side effects

The most common side effects of paclitaxel are

The most common side effects of trametinib are

The most common side effects of pazopanib include

  • High blood pressure
  • Feeling or being sick
  • Diarrhoea
  • Tiredness (fatigue)
  • Skin rash
  • Short term changes to the way your liver, bone marrow Open a glossary item and thyroid Open a glossary item work

There is more information about paclitaxel and pazopanib in our cancer drugs section.

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

Professor Mark Middleton

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
University of Oxford

Other information

This is Cancer Research UK trial number CRUKE/11/033.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8783

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

A picture of Wendy

"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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