A trial of GSK2110183 with chemotherapy for ovarian cancer

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

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 1/2

This trial is looking at a new drug called GSK2110183 alongside carboplatin and paclitaxel for ovarian cancer that has come back after platinum chemotherapy. It is for women who have ovarian cancer, fallopian tube cancer or primary peritoneal cancer. When we use the term ovarian cancer in this summary, we are referring to all 3.

Doctors usually treat ovarian cancer with surgery, followed by chemotherapy. The chemotherapy usually includes a platinum drug Open a glossary item such as carboplatin.

If the cancer comes back, or gets worse, you may have more chemotherapy. But researchers are looking at ways to improve treatment. In this trial they are looking at a drug called GSK2110183.

GSK2110183 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The women taking part in the trial have GSK2110183 alongside the chemotherapy drugs carboplatin and paclitaxel.

The aims of the trial are to

Find the highest safe dose of GSK2110183 you can have with carboplatin and paclitaxel
Learn more about the side effects
See how well this drug combination works for ovarian cancer that has come back after platinum chemotherapy

Who can enter

You may be able to enter this trial if you

Have ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have recovered from side effects of any earlier treatment (apart from hair loss) unless they are very mild
Have satisfactory blood test results
Are able to swallow tablets
Are at least 18 years old
Are willing to use reliable contraception during the trial if there is any chance you could become pregnant

As well as the above, to join the 2nd part of the trial you must have cancer that

Got worse during (or within 4 weeks of finishing) platinum chemotherapy , and you had your last dose of chemotherapy in the last 8 weeks, or that initially responded to platinum chemotherapy, but came back or started getting worse within 6 months of finishing the treatment
Can be seen and measured on a scan

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord (your central nervous system)
Have had major surgery in the last 4 weeks or any other anti cancer treatment (including experimental drugs) in the last 2 weeks
Have had a drug that targets a protein called AKT – your doctor can advise you about this
Have had another type of cancer in the last 5 years apart from non melanoma skin cancer that was completely removed with surgery or any other very early stage cancer (carcinoma in situ ) that was successfully treated
Can’t have carboplatin or paclitaxel for any reason
Have had paclitaxel in the past and your dose had to be reduced because of damage to the nerves in your hands or feet (peripheral neuropathy)
Are known to be very sensitive to drugs that are similar to GSK2110183, carboplatin or paclitaxel – if you have previously had a reaction to carboplatin or paclitaxel you can take part if this can be controlled with medication
Have type 1 diabetes , or have been diagnosed with type 2 diabetes in the last 6 months – you can take part if you were diagnosed with type 2 more than 6 months ago
Have any problem with your digestive system that could affect how you absorb medication
Have any signs of bleeding inside your body (internal bleeding)
Have an infection that needs treatment
Have had a heart attack or have certain other heart problems – the trial doctor can advise you about this
Are known to have HIV, hepatitis B or hepatitis C
Have any other medical condition or need to take any other medication that the trial doctors think could affect you taking part
Are pregnant or breastfeeding

Trial design

This trial is in 2 parts. It aims to recruit 75 people in total. Everybody taking part has carboplatin, paclitaxel and GSK2110183.

In the 1st part of the trial, researchers are trying to find the highest safe dose of GSK2110183 you can have alongside carboplatin and paclitaxel.

The first few patients taking part will have a low dose of GSK2110183. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

In the 2nd part, researchers want to learn more about how well GSK2110183 works. Everybody joining this part of the trial has the highest safe dose identified in part 1.

You have carboplatin and paclitaxel through a drip into a vein once every 3 weeks. You take GSK2110183 tablets each day.

You have the chemotherapy drugs up to 6 times. You then continue to take GSK2110183 on its own. As long as you don’t have bad side effects, you can carry on taking GSK2110183 for as long as it helps you.

During the first 3 weeks of treatment, you have to check your blood sugar level each day. The trial team will give you a machine called a glucometer to do this. Each morning, you prick your finger and the glucometer measures the amount of sugar in a drop of blood. The trial team may ask you to measure your blood sugar level more often than once a day, or to carry on doing it for longer than 3 weeks.

You keep a diary at home. In this, you note down the time you take your tablets and your blood sugar levels. On some days, you also need to note down the time you eat.

Hospital visits

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

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

The trial team will ask your permission to get a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item in the past. They will study the sample to see if the cancer cells have specific changes to genes or proteins that may help them understand why your cancer does or doesn’t respond to the trial drug.

If there isn’t a sample of your cancer available, you can have a new biopsy. But this is optional and you don’t have to give a sample for research if you don’t want to. You can still take part in the trial.

You go to hospital every 3 weeks for the first few months. You have extra blood tests in the first couple of weeks, but you may not need to go to hospital to have these. Each hospital visit lasts between 2 and 9 hours. And you may have to go back the next day.

If you continue taking GSK2110183 on its own after you finish chemotherapy, you may be able to have less frequent hospital visits.

You have a CT or MRI scan after 9, 18 and 28 weeks of treatment and then every 3 months after that.

When you finish the treatment, you see the trial team again between 2 and 4 weeks later. You have a physical examination, blood tests and a CT or MRI scan.

Side effects

As GSK2110183 is a new drug and has not been given to people alongside chemotherapy before, there may be side effects we don’t know about yet. In the small number of people who have taken GSK2110183 on its own, the side effects have included