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 Open a glossary item)
  • 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.

Side effects

As CHR-3996 and tosedostat are new drugs, there may be side effects we don't know about yet. Possible side effects of CHR-3996 include

Possible side effects of tosedostat include

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Rakesh Popat

Supported by

Myeloma UK
NIHR Clinical Research Network: Cancer
University of Leeds

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9275

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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