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

Status:

Closed

Phase:

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 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.