A trial of GSK2256098 and trametinib for advanced cancers

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

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 1

This trial is looking at a new drug called GSK2256098 alongside trametinib for solid tumours that are not responding to other treatments. A solid tumour is any cancer except lymphoma, leukaemia and myeloma.

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.

GSK2256098 is another biological therapy called a FAK inhibitor. FAK is a protein that plays a role in the way cancer grows and spreads. Blocking it may stop cancer spreading.

There are 2 parts to this trial. In the 1st part the researchers want to find out the best dose of each drug to give together.

In the 2nd part the researchers will use the best dose of each drug to find out how well this combination of drugs works for people with mesothelioma of the lung.

The main aims of the trial are to find out

What are the best doses of GSK2256098 and trametinib to give together
The side effects of giving these drugs together
More about what happens to GSK2256098 and trametinib in the body
How well GSK2256098 alongside trametinib works for people with mesothelioma of the lung

Who can enter

There are 2 parts to this trial. You may be able to join part 1 of this trial if all of the following apply. You

Have a solid tumour
Have an area of cancer that can be measured on a scan
Have had at least 1 course of chemotherapy
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Are able to swallow tablets or capsules
Have satisfactory blood test results
Are willing to use reliable contraception during treatment and for 3 weeks afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years old

To join part 2 of the trial you must have mesothelioma of the lung.

You cannot join this trial if any of these apply

Your cancer has spread to your brain
Your cancer is pressing on your spinal cord causing spinal cord compression
You have had chemotherapy in the past 3 weeks (6 weeks if you have had chemotherapy called nitrosourea or a drug called mitomycin C)
You have had major surgery, radiotherapy or immunotherapy in the past 4 weeks
You have had an experimental drug as part of another clinical trial in the past month
You are taking other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
You are taking warfarin (you should not stop taking warfarin without first talking to your doctor)
You have had another cancer in the past 3 years apart from non melanoma skin cancer
You have a problem with your digestive system that could affect the way your body absorbs medication
You have certain heart problems, lung conditions or eye conditions (the trial team can advise about this)
You have HIV, hepatitis B or hepatitis C
You have any other medical condition or mental health problem that the trial team think could affect you taking part in the trial
You are pregnant or breastfeeding

Trial design

This is an international phase 1 trial. The researchers need 48 people to join. The trial is in 2 parts.

In the 1st part the researchers want to find the highest dose of GSK2256098 and trametinib to give together. The first few patients taking part will have a low dose of the drugs. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the highest dose they can safely give. This is called a dose escalation study.

In part 2 of the trial the researchers want to find out how well GSK2256098 alongside trametinib works for people with mesothelioma of the lung. They will use the highest safe doses they found in part 1.

GSK2256098 is a tablet you take twice a day, 30 minutes after having a light meal. Trametinib is a tablet you take it once a day, 2 hours after having a light meal. You can continue treatment as long as it is helping you and the side effects aren’t too bad.

If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item .

They will also ask for extra samples of your cancer and for blood samples during your treatment. You must agree to some of these to take part in the trial. But some you don’t have to agree to. The trial team will tell you more about this.

They will use these samples to find out how GSK2256098 and trametinib work in the body. They will also see if there is something about your cancer that makes it more or less likely to respond to GSK2256098 and trametinib.

Hospital visits

You see the doctor to have some tests before you agree to take part in this trial. These tests include

A physical examination
Blood tests
Heart trace (ECG )
Heart scan (ECHO )
Eye test
Urine test
CT scans or MRI scans (if needed)
Tests to find out how well your lungs are working (Breathing tests)

During treatment you see the doctor every week for the first 5 weeks and then every 4 weeks for a physical examination and blood tests.

You have a heart trace 3 times in the first month and then every 8 weeks. You have a heart scan 3 times in the first 5 months and then every 3 months. You have a CT scan or MRI scan and breathing tests every 2 months.

At the end of treatment you see the doctor for