A trial looking at RO5126766 for solid tumours and myeloma

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 RO5126766 to treat solid tumours and a type of cancer called myeloma. It is for people with a solid tumour Open a glossary item or myeloma who have no standard treatment options available to them.

More about this trial

Researchers are looking for new drugs that will help people whose cancer is getting worse despite having treatment. In this trial, they are looking at a drug called RO5126766.

RO5126766 is a type of drug called a cancer growth blocker. It targets 2 proteins that normally send signals to cells telling them to divide and grow. RO5126766 works by blocking the action of these proteins and hopefully causing the cancer to shrink or stop growing.

The aims of this trial are to

Find out how often people should have RO5126766 (twice a week, or 3 times a week)
Learn more about the side effects of this drug and how best to reduce these side effects
See what happens to RO5126766 in the body

Who can enter

You may be able to join this trial if all of the following apply.

You have a solid tumour or myeloma that has come back despite having standard treatment , or there isn't a standard treatment available and if you have a solid tumour you have at least one area of cancer that can be measured or monitored
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)
If you have a solid tumour, a sample of your cancer that was removed when you had surgery or a biopsy is available for the trial team to test. If you have myeloma, a sample of bone marrow is available for testing
Your cancer cells have a change (mutation ) in genes called BRAF, KRAS or NRAS (the trial team will test for this)
You are willing to use reliable contraception for 4 weeks before the trial, during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
You are at least 18 years old

You cannot join this trial if any of these apply. You

Have cancer that has spread to your brain
Have had chemotherapy in the last 4 weeks (or in the last 6 weeks if you had a chemotherapy drug called a nitosourea or a drug called mitomycin C)
Have had biological therapy or treatment on a trial in the last 4 weeks (you may still be able to take part if you are in an observational study)
Have had radiotherapy in the last 4 weeks, unless it was for symptom control only
Have had hormone therapy in the last 2 weeks (with the exception of some men with prostate cancer)
Are still having serious side effects from any anti cancer treatment
Have had major surgery to your chest or stomach and you have not yet fully recovered
Are known to be HIV, hepatitis B or hepatitis C positive
Have certain heart problems (the trial team can advise you about this)
Have any other medical condition that the trial doctor thinks could affect your taking part
Have taken other medication in the last 7 days that affects body substances called CYP enzymes (your doctor can advise you about this)

Trial design

This is a phase 1 trial. The researchers need about 38 people to take part.

The trial is in 2 parts.

In part 1, people taking part had RO5126766 either

Twice a week (Monday and Thursday) or
3 times a week (Monday, Wednesday and Friday)

How often they had it depended on when they joined the trial.

In part 2, everyone has RO5126766 twice a week on Monday and Thursday. This was found to be the best schedule in the first part of the trial. The trial team will explain exactly how and when to take RO5126766.

You have RO5126766 as a capsule after a light meal and at least 1 hour before your next meal. Swallow the capsule whole, do not crush or chew it.

If at any point your cancer starts to get worse, or you have serious side effects, you will stop the trial treatment. Your doctor will discuss whether there are other treatment options for you.

If it is helping, you may have RO5126766 for at least a year. After a year, the trial doctor will discuss whether it would be a good idea to continue treatment with RO5126766.

Hospital visits

You will see the doctors and have some tests to help them decide if you are able to take part in the trial. This may involve more than one hospital appointment. The tests include

Blood tests
Physical examination including an eye examination
Tests to find out how well your liver and kidneys are working
CT scan or MRI scan of your chest, stomach and pelvis
Heart trace (ECG )
Heart scan (echocardiogram or MUGA scan )

On the first day of your treatment you stay in hospital for 2 nights so that you can have regular blood tests. You have blood tests on 9 different occasions over 2 days. The blood tests look at how much of the drug is in your blood and the effect it is having on your body.

You stay in hospital for 2 nights to have these blood tests again 3 weeks later. You won’t have to stay overnight in hospital for any of your other treatments.

You go to hospital on the first day of every week for 2 months. You have RO5126766 at hospital on these days. After 2 months, you may only need to go to hospital every 2 weeks. After a further 2 months you may only need to visit hospital every month. At these appointments you see a doctor and have blood tests. You have an eye examination once a month for 2 months, then every 2 months after that.

You have a heart scan at the start of the second month of treatment. You have a CT scan or MRI scan every 2 months during treatment. You may also have blood tests to test for tumour markers Open a glossary item to see how well the treatment is working.

You go to hospital about 1 month after you finish treatment and you may have some of the above tests repeated. If you have any side effects, the trial team will keep in touch with you until these get better. This may be at a hospital appointment or over the phone if you can't get to hospital.

Side effects

As RO5126766 is a new drug, there may be side effects we don’t know about yet. Possible side effects include

Itching skin and skin rash
Sore mouth
Eye problems (a doctor will examine your eyes regularly)
Diarrhoea
Feeling or being sick
Tiredness (fatigue)
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

While some of these side effects may get worse during the first few doses of RO5126766, it is possible that some side effects will become less as treatment continues.