
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called GSK2816126 for non Hodgkin lymphoma (NHL), myeloma and other solid tumours. The trial is open to people who have a , myeloma or a type of NHL called diffuse large B cell lymphoma or follicular lymphoma that has come back after treatment.
Doctors can treat these cancers with
Unfortunately sometimes these treatments don’t work and the cancer continues to gets worse during treatment or comes back after treatment. Researchers are always looking for new treatments to help these people.
Diffuse large B cell lymphoma (DLBCL), follicular lymphoma, myeloma and other solid tumours need an called EZH2 to grow. GSK2816126 is a new drug. We know from
that it can block EZH2 and so may stop these lymphomas growing. This will be the first time GSK2816126 is given to people.
There are 2 parts to this trial. In the first part the researchers want to find the highest safe dose of GSK2816126 to give. This part will be open to people with
In the 2nd part the team will use the best dose found in part 1 to treat people with DLBCL, follicular lymphoma that has transformed from low grade to high grade and myeloma.
The main aims of this trial are to
You may be able to join part 1 of the trial if you have one of the following
And all of the following apply
To join part 2 of the trial you must have diffuse large B cell lymphoma, myeloma or transformed follicular lymphoma with certain changes to the enzyme EZH2 (the trial team will test for this).
You cannot join this trial if any of these apply. You
This is an international phase 1 trial. Everyone will have GSK2816126.
There are 2 parts to this trial. For the 1st part the researchers need 40 people to join. For the 2nd they need 129 people.
In the 1st part, the first few patients will have a low dose of GSK2816126. 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 best dose. This is called a dose escalation study.
The researchers will use the best dose of GSK2816126 they found in part 1 for part 2.
You have GSK28162126 as a drip through a central venous access device, such as a central line, portacath or PICC line. It takes 2 to 4 hours. You have it twice a week for 3 weeks and then a week of no treatment. Each 4 week period is called a cycle of treatment.
You can continue having GSK2816126 as long as it is helping and the side effects aren’t too bad.
The researchers will ask for a sample of your cancer that was removed when you had a . If this isn’t available you must be willing to have a biopsy done before you start any treatment. The researchers will use this sample to look for the changes in the EZH2 enzyme.
The team may also ask people joining part 1 of the trial to have 2 more biopsies. They will use these samples to look for substances in the tissue () that may tell them how well GSK2816126 is working. You don’t have to agree to have these 2 biopsies done. You can still take part in the trial.
People joining part 2, must be willing to have 2 more biopsies done. The researchers will use these to find out how GSK2816126 affects the lymphoma or myeloma.
You see the doctor to have some tests before taking part in this trial. These tests include
For 24 hours after your first treatment you wear a small monitor. This will take an electrical recording of your heart beat for the 24 hours. You will stay in hospital overnight while this is been done.
During treatment you see the doctor once a week for the first 4 weeks for a physical examination and blood tests. You then see the doctor every 4 weeks for a physical examination and blood tests.
You have a heart trace on weeks 1, 2 and 3 and then every 4 weeks. You have a CT scan at week 8 and then every 12 weeks. If you have a solid tumour you have a CT scan every 8 weeks.
After treatment you see the doctor for the same tests you had at the start.
This is the first time GSK2816126 has been tested in people so there may be side effects we don’t know about yet. The side effects may include
A member of the trial team will talk to you about the possible side effects before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor P Johnson
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.