CXD101: a phase 1 trial looking at a new treatment called CXD101 for people with relapsed or refractory lymphoma and for other cancers

This is a phase 1 (early phase) trial of an experimental treatment. Little is known about the safety and effectiveness of this treatment. You might not benefit from the treatment, but the trial will give important information about this new treatment, which could help other people in the future.

Initial results from this trial have been published, but it is still recruiting new participants.


Purpose of trial

The aim of this trial is to find out more about using a new treatment CXD101 to treat lymphomas and other types of cancer. The trial is for people whose lymphoma has relapsed (come back) or is refractory (has not responded to treatment) and for people with advanced-stage solid tumours or myeloma. The trial aims to find out:

  • the side effects
  • how well the treatment works
  • how the treatment behaves in the body.

Treatments

CXD101 is a targeted drug that works by blocking substances called ‘histone deacetylases’, which affect the activity of many proteins in different types of cells, including cancer cells. Blocking histone deacetylases in cancer cells could cause the cells to die or control their growth. 

This trial is in two parts. Part 1 has already been completed and found the best dose of CXD101 to be used in part 2. All new participants are entering part 2 of the trial, which is testing a 20 mg dose of CXD101, taken twice a day. 

Everyone in this trial takes CXD101 capsules twice a day for 5 days. You then have a break from treatment for the rest of each 3-week period. This is a ‘cycle’ of treatment.

Everyone on this trial can continue to have the trial treatment for as long as it is benefitting them.


Who can enter

Your consultant can advise you whether this trial might be suitable for you.

Around 50 people are needed for this trial.

You may be able to enter if:

  • You have an advanced-stage solid tumour, myeloma or lymphoma.
  • Your cancer is not responding to treatment or there is no suitable standard treatment.
  • A sample of your biopsy is available for tests.
  • Your cancer is measurable by the tests used in the trial.
  • You are well enough to take part in this trial.
  • Your blood and other health test results are satisfactory.
  • You have recovered from the effects of previous treatments.
  • You and your partner are willing to use reliable contraception, including a barrier method (for example, condoms) if there is any chance of you or your partner becoming pregnant.
  • You are 18 or over.

You won't be able to enter if:

  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You have HIV, hepatitis C or hepatitis B.
  • You have had other treatment for cancer in the last 4 weeks, unless it was radiotherapy given only to relieve symptoms (palliative).
  • You have had major surgery in the last 4 weeks.
  • Your cancer is in your central nervous system (brain and spinal cord) unless it is has not got worse over the last 2 months. 
  • You still have significant side effects from your previous treatment. 
  • You can’t swallow tablets or capsules.
  • You have any digestive problems that might make it difficult for you to absorb the trial treatment.
  • You have any major health problems, including an infection that isn’t under control, or heart problems.
  • You are taking part in another trial involving treatment.
  • You have been treated with a similar drug before.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at https://clinicaltrials.gov/show/NCT01977638.

 

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