A trial of GSK2816126 for non Hodgkin lymphoma, myeloma and other solid tumours

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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 GSK2816126 for non Hodgkin lymphoma (NHL), myeloma and other solid tumours. The trial is open to people who have a solid tumour Open a glossary item , myeloma or a type of NHL called diffuse large B cell lymphoma or follicular lymphoma that has come back after treatment.

More about this trial

Doctors can treat these cancers with

Chemotherapy
Radiotherapy
Biological therapy

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 enzyme Open a glossary item called EZH2 to grow. GSK2816126 is a new drug. We know from laboratory studies 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

Non Hodgkin lymphoma (NHL)
Myeloma
A solid tumour

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

Find the highest safe dose of GSK2816126
See if it can help people with DLBCL, transformed follicular lymphoma and myeloma

Who can enter

You may be able to join part 1 of the trial if you have one of the following

Non Hodgkin lymphoma
Myeloma
A solid tumour apart from prostate cancer that has stopped responding to hormone therapy

And all of the following apply

Your lymphoma, myeloma or solid tumour has continued to get worse during treatment or came back after treatment
You have satisfactory blood test results
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are willing to use reliable contraception during treatment and for 3 months afterwards
You are at least 18 years old

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

Are currently having treatment. If you are only having steroids to control symptoms you must be stable for at least a week before taking part
Have prostate cancer and are on hormone therapy, apart from luteinizing hormone releasing hormone (LHRH) agonists. If you stopped your hormone therapy 4 to 6 weeks ago or are having a low dose of steroids (10mg a day) you may be able to take part
Have had major surgery, radiotherapy or immunotherapy in the past 4 weeks. If you had radiotherapy to control symptoms to a single area it must have been in the past 2 weeks. If you had a stem cell transplant using your own stem cells you can join the trial if the transplant was at least 100 days ago and you have no ongoing side effects
Have had chemotherapy in the past 3 weeks (for continuous chemotherapy or weekly chemotherapy in the past 2 weeks)
Have had an experimental drug as part of another clinical trial in the past 4 weeks
Still have side effects from any previous treatment apart from hair loss or a drop in a type of white blood cells called lymphocytes
Are taking certain medications (the trial team can advise you about this)
Are taking warfarin
Have certain heart problems (the trial team can advise you about this)
Have diabetes that isn’t controlled with medication
Have HIV, hepatitis B or hepatitis C
Have any other medical or mental health problems that the trial team thinks could affect you taking part in the trial
Are allergic to the drugs, or any of their ingredients, used in the trial
Are pregnant or breastfeeding

Trial design

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 biopsy Open a glossary item . 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 (biomarkers Open a glossary item ) 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.

Hospital visits

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

A physical examination
Blood tests
Heart trace (ECG )
Heart scan (ECHO )
CT scan
PET scan
Bone marrow test

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.

Side effects

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

Changes to your heart beat
Feeling faint
Weakness
Itchiness
Skin rash
Swelling
Difficulty breathing
Skin changes, bleeding, swelling or pain at site of infusion
Feelings of confusion or anxiety
An allergic reaction causing a raised, itchy rash (hives) and swelling of the mouth or throat

A member of the trial team will talk to you about the possible side effects before you agree to take part in the trial.