A trial looking at PM01183 for pancreatic cancer

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

Cancer type:

Pancreatic cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug PM01183 to treat pancreatic cancer that has spread to other parts of the body.

Pancreatic cancer that has spread to other parts of the body is sometimes called advanced pancreatic cancer. Doctors usually treat this with chemotherapy including the drug gemcitabine. Sadly this doesn’t always work very well so doctors want to find new drugs to help people with advanced pancreatic cancer.

PM01183 is a new drug that affects how cancer cells divide and grow. Researchers want to find out if it can help people with advanced pancreatic cancer.

The aim of this trial is to find out

If PM01183 can help people with advanced pancreatic cancer that has come back or did not go away with chemotherapy
About the side effects

Who can enter

You may be able to enter this trial if you

Have pancreatic cancer that has spread to other parts of your body (advanced pancreatic cancer)
Have pancreatic cancer that didn’t get better with treatment or came back after treatment with gemcitabine
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood tests results
Are well enough to have treatment
Are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
Are aged between 18 and 75 years old

You cannot enter this trial if you

Have a type of pancreatic cancer known as neuroendocrine or mucinous
Have already had more than one course of chemotherapy for your pancreatic cancer
Have cancer that has spread to your brain
Have had any other cancer, apart from carcinoma in situ of the cervix, non melanoma skin cancer or carcinoma in situ of the bladder that was successfully treated at least 3 years ago
Are HIV, hepatitis B or C positive
Have had chemotherapy in the last 2 weeks
Have had radiotherapy in the last month
Have had PM01183 before
Have a swollen tummy due to a collection of fluid (ascites )
Have a blood clot in your leg (deep vein thrombosis or DVT) that is not getting better with treatment
Have had a heart attack in the last year or any other serious heart condition that is not well controlled with medication
Have an infection that cannot be controlled by medication, or any other condition that could make it unsafe for you to take part in this trial
Have had an experimental drug as part of another trial if it is still affecting you - your doctor can discuss this with you

Trial design

This trial will recruit up to 43 people. Every one taking part has PM01183.

You have PM01183 through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You can have PM01183 for as long as it is helping you and you want to continue with the treatment.

If you agree to take part in this study, the researchers will ask for a sample of tissue taken when your cancer was diagnosed. If you don’t want to give tissue samples for this study, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

Blood tests
Physical examination
Heart trace (ECG )
Heart ultrasound (echocardiogram ) or MUGA scan
CT scan or MRI scan

You have physical examinations and blood tests frequently while you are having treatment.

You have a CT scan or MRI scan every 6 weeks while you have treatment and until your cancer starts to grow again.

When you stop treatment the researchers will see you 30 days later for blood tests.

If you stop treatment because your cancer has started to grow, the researchers will see you every 3 months for a year.

If you stop treatment and your cancer has not got worse then the researchers see you every 6 weeks until your cancer starts to grow again.

Side effects

The most common side effects of PM01183 are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Tiredness (fatigue)
Diarrhoea
Constipation
Loss of appetite