A trial looking at a new drug APD515 to treat cancer related dry mouth

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

Cancer type:

All cancer types




Phase 2

This trial is looking at a new drug APD515 to treat people with cancer who have a dry mouth.

Doctors know that a dry mouth is a common problem for people with advanced cancer.

A dry mouth can be treated with mouth washes and artificial saliva. But this treatment doesn’t always work very well.

Doctors want to find out if APD515 works better than existing treatment for people with a dry mouth.

The aim of this trial is to find out

  • If APD515 can help people with a dry mouth
  • About the side effects

Who can enter

You may be able to enter this trial if you

  • Have any cancer apart from non melanoma skin cancer
  • Are having treatment for your cancer as long as the treatment does not cause a sore mouth
  • Finished your first course of chemotherapy more than a month ago
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have had a dry mouth for 2 weeks or more
  • Have satisfactory blood test results
  • Are able to produce saliva Open a glossary item when stimulated to do so
  • Are willing to use reliable contraception during the study and for 14 days 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 a rare condition called Sjögren’s syndrome
  • Have had radiotherapy to the mouth or salivary glands
  • Have a sore mouth or mouth infection
  • Are allergic to the drug APD 515
  • Have used drugs that stimulate saliva production in the last 2 weeks
  • Are taking certain drugs for your heart - your doctor will discuss this with you
  • Have any other problem which would mean the study wasn’t suitable for you
  • Have taken part in a clinical trial in the last month
  • Have had a heart attack in the last 6 months
  • Have had major bowel surgery in the last 6 months
  • Have a blockage in your bowel or bladder (urinary system)
  • Are pregnant or breastfeeding

Trial design

This is a randomised trial. The people taking part are put into 1 of 2 treatment groups. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in as everyone has treatment that looks the same. This is called a ‘double blind’ trial.  

APD515 is a liquid that you spread onto the lining of your mouth, and leave there without swallowing for 2 minutes. You then swallow any remaining liquid.

The people in group 1 have

  • APD515  for a week
  • A week with no treatment
  • A dummy drug (placebo) for a week

The people in group 2 have

  • A placebo for a week
  • A week with no treatment
  • APD515 for a week

You fill out a questionnaire before you start treatment, and twice a week when you have treatment. The questionnaire will ask about any side effects you have had and about your dry mouth. This is called a quality of life study.

Hospital visits

You see the doctors and have some tests before you start each week of treatment and on the last day of each treatment. The tests include

  • Physical examination
  • Blood tests
  • An examination of your mouth
  • Heart trace (ECG Open a glossary item)
  • Tests to see how much spit (saliva Open a glossary item) you produce

Researchers will ring you at home in the middle of each treatment week, to find out how you are.

Once you have finished your 2nd week of treatment there are no more hospital visits for the trial.

Side effects

The most common side effects of APD515 are

  • Increased sweating
  • Watery eyes
  • Tummy (abdominal) pain
  • Feeling sick
  • Diarrhoea

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 Andrew Davies

Supported by

Acacia Pharma Ltd
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8645

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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