A trial of GSK2256098 for solid tumours

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 drug called GSK2256098 for people who have a solid tumour Open a glossary item that is not responding to other treatment. A solid tumour is any type of cancer, except for leukaemia or lymphoma.

Some types of cancer produce high levels of a protein called focal adhesion kinase or FAK. FAK plays a role in the way cancer grows and spreads. Blocking it may stop cancer spreading.

In this trial, researchers are looking at a drug called GSK2256098 which can block FAK. It is known as a FAK inhibitor.

The aims of this trial are to find out

The highest dose of GSK2256098 you can have safely
What the side effects are
How much of the drug gets into the bloodstream and how long your body takes to get rid of it
If there is something about your cancer that makes it more or less likely to respond to the drug

Who can enter

You may be able to enter this trial if you

Have a solid tumour that is not responding to standard treatment or for which there is no standard treatment available
Have satisfactory blood test results
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 and absorb tablets
Are at least 18 years old
Are willing to use reliable contraception from 2 weeks before the trial (for women), during the trial and until at least 3 weeks after the last dose of the trial drug, if there is any chance you or partner could become pregnant

To join parts 2 or 3 of the trial, you must have a type of cancer that is known to produce high levels of FAK. This includes mesothelioma, ovarian cancer, pancreatic cancer, head and neck cancer, stomach cancer, womb cancer, non small cell lung cancer and prostate cancer.

To join part 4 of the trial, you must

Have glioblastoma multiforme that has come back or got worse despite having other treatment
Have already had chemotherapy that included the drug temozolomide

You cannot enter this trial if you

Have cancer that started in your brain, unless you are joining part 4
Have cancer that has spread to your brain or spinal cord and has not been treated or is causing symptoms - you may be able to take part if you have had cancer in your brain successfully treated and you have not needed to take steroids or medicine to prevent fits for at least 2 months
Have had an experimental drug as part of another clinical in the last 4 weeks and there is any chance some of the drug could still be in your body
Have had chemotherapy in the last 3 weeks (or 6 weeks if you had a drug called mitomycin C or a type of chemotherapy called a nitrosourea )
Have had major surgery or immunotherapy in the last 4 weeks
Have had radiotherapy in the last 4 weeks unless it was radiotherapy to treat symptoms (palliative radiotherapy) or radiotherapy to prevent cancer spread in an area where you had a biopsy taken
Are known to be very sensitive to drugs similar to GSK2256098
Take a drug called warfarin (it is important that you don’t stop taking any medication without speaking to your doctor)
Have not recovered from side effects of other cancer treatment (apart from hair loss) unless they are very mild
Have certain heart problems
Have any other condition that the trial doctors think could affect you taking part
Are pregnant or breastfeeding

As well as the above, you cannot join part 4 of the trial if you have had bleeding in or around your brain.

Trial design

This is a phase 1 study that will recruit about 160 people all together. There are 5 different parts to the study.

In part 1, the researchers are looking for the highest dose of GSK2256098 that you can safely have. The first few patients taking part will have a low dose of the drug. 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, the researchers will find out more about how safe GSK2256098 is and what happens to it in your body (pharmacokinetics Open a glossary item ), as well as finding out how it affects cancers with high levels of FAK.

In part 3, they will study how different doses of GSK2256098 affect your body. This is called pharmacodynamics Open a glossary item . None of the doses they look at will be any higher than the highest safe dose they find in part 1. But studying different doses of the drug may mean that people can have a lower dose in future. This part of the study includes the collection of hair, skin and tumour tissue.

In part 4, the researchers want to learn more about the safety and pharmacokinetics of GSK2256098, but this part of the study is only for people who have a type of brain tumour called a glioblastoma multiforme that has come back after other treatment.

In part 5 of the study, the researchers will look at the amount of GSK2256098 in your blood at different times during treatment. They will also see if it interacts with other medication.

Everybody in the trial takes GSK2256098 tablets each day. As long as you don’t have bad side effects, you can carry on having the drug for as long as it helps you.

Hospital visits

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

Physical examination
Blood and urine tests
Heart trace (ECG )
CT scan or MRI scan

The trial team will get a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item .

You go to hospital once a week for the first 3 or 4 weeks of treatment and then once every 3 weeks for as long as you continue having the trial drug. Each visit lasts between 2 and 4 hours. You have a physical examination, blood tests and urine tests each time. You have an ECG every 3 weeks during treatment and a CT or MRI scan every 6 weeks.

Depending on which part of the trial you join, the trial team may take biopsies Open a glossary item of your cancer. They may also take skin biopsies and hair samples. Researchers will use samples of your cancer to look for substances called biomarkers which can help them to see how well the treatment is working. Samples of skin and hair can also help them see what effect the drug is having.

If you have a biopsy of your cancer, a member of the trial team will numb your skin and put a needle through the skin into the cancer to remove some cells.

If you have skin biopsies, they will take small samples of skin from your bottom. They will numb the area beforehand each time and you may need a few stitches afterwards.

If you give hair samples, they will use tweezers to pluck about 10 hairs from your head.

Depending on which part of the trial you join, you may have some extra blood tests before and after taking some doses of GSK2256098. This is to see how much of the drug gets into your bloodstream, and how long your body takes to get rid of it. The trial team will give you more information about this.

When you finish treatment, you go back to see the trial team about 3 weeks later. You have a physical examination, an ECG, blood and urine tests.

Side effects

As GSK2256098 is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have included

Feeling or being sick
Diarrhoea
Loss of appetite and weight loss
Feeling tired, weak, dizzy or faint
Headache
Swollen legs
Liver of kidney problems
A drop in the number of red blood cells (anaemia )
Constipation
Muscle cramps or muscle damage
High body temperature (fever)
Taste changes
Itching
Pain in your tummy (abdomen)

The trial team will give you more information about other less common side effects.

If you have biopsies taken from your cancer, the area can be tender for a few days afterwards and there is a small risk of infection or bleeding from the site.

If you have skin biopsies, you may have some pain or bruising and there is a small risk of infection or bleeding. Taking hair samples can also be a bit painful.

You must not drink red wine during the trial or eat fruits such as Seville oranges and grapefruit (or drink their juices). The trial team will also advise you to reduce the amount of time you spend in the sun. If you need to be outdoors, you will need to protect your skin with loose fitting clothing, a hat and sunscreen.