A trial looking at CHR-3996 and tosedostat for myeloma (MUK three)

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

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 1/2

This trial is looking at 2 new drugs, CHR-3996 and tosedostat (pronounced toe-sed-oh-stat) for people with myeloma that has come back or did not go away following treatment.

More about this trial

Myeloma that has come back or did not go away following treatment can be more difficult to treat.

CHR-3996 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Blocking them may stop cancer growing.

Tosedostat also stops signals that cancer cells use to divide and grow. Doctors want to find out if combining CHR-3996 and tosedostat will help people with myeloma.

The aims of this trial are to find out

If CHR-3996 alone causes side effects
The best dose of CHR-3996 and tosedostat to give
About the side effects
If these new drugs help people with myeloma that has come back or did not go away following treatment

Who can enter

You may be able to enter this trial if you

Have myeloma that has come back or did not go away following treatment
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood and urine test results
Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have had any other treatment in the last 4 weeks
Have had steroids in the last 7 days (you must not stop taking them unless told to by your doctor)
Have had radiotherapy unless it was for symptom control only
Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least a year ago
Have certain heart problems
Are HIV, hepatitis A, hepatitis B or hepatitis C positive
Have an infection that cannot be controlled with medication, or any other condition that could make it unsafe for you to take part in this trial
Have problems with your digestive system that may interfere with how the trial drug is absorbed
Are pregnant or breastfeeding

Trial design

This trial will recruit up to 66 patients from the UK.

CHR-3996 and tosedostat are tablets. You take them daily until your cancer starts to grow again or you do not want to take them anymore. The dose and combination of drugs you have depends on when you join the trial.

The trial is in 2 parts.

In the first part of the trial a few patients have CHR-3996 alone. If they do not have any serious side effects the next patients have CHR-3996 and tosedostat together and have the lowest dose.

If they don’t have any serious side effects Open a glossary item , 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 second part of the study patients have the best dose of CHR-3996 and tosedostat found in the earlier part of the study. If you were previously treated at a lower dose you may be able to change to the ‘best dose’. Your doctor will explain.

Hospital visits

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

Blood tests
Physical examination
Heart trace (ECG )
Bone marrow test (if needed)
Urine tests (if needed)

If you need bone marrow tests or urine tests your doctor will discuss these with you.

Everybody will see the doctor, have blood tests and heart trace tests frequently during the first 8 weeks of the trial. After 8 weeks you see the doctors and have these tests less often.

When you stop treatment you see the doctors, have blood tests and a heart trace. The doctors then see you regularly until your cancer starts to grow again.