A trial of CXD101 for advanced cancer

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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 CXD101 to treat cancers that have spread (advanced cancers) and haven’t responded as hoped to previous treatment. This study is for people who have advanced cancer Open a glossary item and there is no standard treatment Open a glossary item available to them.

More about this trial

CXD101 is a drug that blocks substances (enzymes Open a glossary item) in the body called histone deacetylases (pronounced dee-as-et-isle-azes). Cells need these to grow and divide. Blocking them may stop cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or HDAC inhibitors.

We know from laboratory studies Open a glossary item that CXD101 may be able to stop cancer cells growing. This trial will be the first time CXD101 has been given to people.

The main aims of this trial are to

  • Find out the highest safe dose of CXD101
  • See if it can help people with advanced cancer

Who can enter

You may be able to join this trial if

  • You have cancer that has spread and there is no standard treatment Open a glossary item available to you
  • Your cancer can be measured on a scan
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 4 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply

  • Your cancer has spread to your brain unless it hasn’t got worse for 2 months or more
  • You are currently taking any anti cancer medication apart from drugs called bisphosphonates Open a glossary item for bone damage, or a stable dose of steroids
  • You have had radiotherapy in the last month apart from radiotherapy for symptom control (palliative radiotherapy). If you had radiotherapy to a small area, such as a small cancer in your bone, it must be at least 2 weeks ago
  • You have had hormone therapy Open a glossary item or immunotherapy Open a glossary item in the last month
  • You have had an experimental drug as part of another clinical trial in the last month
  • You still have side effects from previous anti cancer treatment unless they are mild
  • You have had major surgery in the last month
  • You have HIV, hepatitis B or hepatitis C
  • You have an infection that needs to be treated
  • You have a problem with your digestive system Open a glossary item that means you are not able to swallow tablets or capsules
  • You have had a drug that acts in the same way as CXD101 (the trial team can advise about this)
  • You have certain heart problems (the trial team can advise about this)
  • You are pregnant or breastfeeding

Trial design

This is a phase 1 trial . Everyone taking part will have CXD101. The first few people will have a low dose of CXD101. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

While taking CXD101 you will continue to have the same dose you started on.

When the team find the highest dose of CXD101, they will ask about another 20 people to join the trial. This will bring the total number of people they expect to join to between 25 and 40.

If you have a solid tumour Open a glossary item, the researcher will take a small piece of your cancer tissue (biopsy Open a glossary item) to check for a substance called HR23B. You must agree to this before you can join this part of the trial.

CXD101 is a capsule that you take twice a day for 5 days. This is then repeated every 3 weeks. You cannot eat for at least 2 hours before taking the capsules and you must wait at least 1 hour afterwards before eating. Your doctor will tell how many capsules to take and when to take them.

You can continue treatment with CXD101 as long as it is helping you and the side effects aren’t too bad.

If you agree to take part in this trial, the researchers will ask for a sample of your cancer that was removed when you had surgery or a previous biopsy Open a glossary item.

They may ask for another sample of your cancer tissue during the trial. If you don’t want to give this sample, you don’t have to. You can still take part in the study.

They will also ask for some extra blood samples to find out what happens to CXD101 in the body.

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 Open a glossary item)
  • Urine test
  • Eye tests
  • CT scan
  • Bone marrow test (for people with lymphoma Open a glossary item or myeloma Open a glossary item)

During treatment you see the doctor to have the same tests

  • 3 times in the 1st week
  • 1 to 2 visits per week for the next 5 weeks
  • Then 2 visits every 3 weeks

Every 6 weeks you have a CT scan or MRI scan.

After you finish treatment, your doctor will tell how often they want to see you.

Side effects

This is the first time CXD101 has been tested in people so there may be side effects we don’t know about yet. The side effects may include

Your doctor will talk to you about all the possible side effects before you agree to take part in the trial.

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.

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

Chief Investigator

Professor M Middleton

Supported by

Celleron Therapeutics Ltd
Experimental Cancer Medicine Centre (ECMC)
Oxford University Hospitals NHS Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

6423

Print page
Questions to ask your doctor about clinical trials
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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