A trial of olaparib for pancreatic cancer that has spread (POLO)

Cancer type:

Pancreatic cancer

Status:

Open

Phase:

Phase 3

This trial is looking at olaparib for pancreatic cancer that has spread. It is open to people whose pancreatic cancer has an inherited Open a glossary item change in BRCA 1 Open a glossary item or BRCA 2 Open a glossary item.

More about this trial

Doctors can treat pancreatic cancer that has spread, with chemotherapy. This won’t cure it but can slow the growth of the cancer. Researchers think that olaparib may also slow down the growth of pancreatic cancer that has an inherited change in BRCA1 or BRCA2.

Healthy cells can repair themselves if they get damaged. BRCA1 and BRCA2 help repair the damage. A change (mutation) in BRCA1 or BRCA2 means that cells in your cancer are already having problems repairing damage.

An enzyme Open a glossary item called PARP also helps to repair the damage. Researchers hope that if they can also stop the PARP enzyme from working, the cancer cells will not be able to repair themselves and die.

Olaparib is a type of biological therapy called a PARP inhibitor. It blocks the PARP enzyme.

In this trial people will have either olaparib or a dummy drug (placebo) Open a glossary itemafter having chemotherapy.

The aims of the trial are to find

  • How well olaparib works for people with pancreatic cancer who have an inherited change in BRCA1 or BRCA2
  • How safe olaparib is
  • More about the side effects of olaparib
  • How olaparib affects quality of life Open a glossary item

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have a type of pancreatic cancer called an adenocarcinoma Open a glossary item that has spread to another part of your body
  • Have a certain type of inherited change in BRCA1 or BRCA2 (the trial team can advise you about this)
  • Have had chemotherapy containing a platinum drug Open a glossary item and your doctor has stopped this until the cancer starts to grow again
  • Have an area of cancer that can be measured on a scan or your scan shows that the cancer isn’t getting worse
  • Have satisfactory blood test results
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Are willing to use reliable contraception during treatment and for at least 3 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have cancer spread only to your brain or spinal cord. You may be able to join if your cancer has spread to another part of your body and the cancer spread in your brain or spinal cord has been treated with radiotherapy Open a glossary item at least 2 weeks ago, you have no significant side effects and don’t take a big dose of steroids
  • Have had anti cancer treatment within 4 weeks of starting treatment in this trial. If you had radiotherapy to relieve symptoms it must at least 2 weeks ago. If you are having medication for cancer spread to the bones, such as bisphosphonates Open a glossary item or denosumab, you must have started them at least 2 weeks before starting treatment
  • Have ongoing side effects from previous treatment apart from hair loss and mild to moderate peripheral neuropathy Open a glossary item
  • Have a myelodysplastic syndrome Open a glossary itemor acute myeloid leukaemia Open a glossary item
  • Have had another cancer in the past 5 years
  • Have had major surgery within 2 weeks of starting treatment
  • Have had a bone marrow transplant Open a glossary itemfrom a donor
  • Had a blood transfusion Open a glossary itemin the past 4 months. If your transfusion was only red blood cells Open a glossary itemor platelets Open a glossary item you may be able to join
  • Have already had olaparib or another PARP inhibitor
  • Are allergic to olaparib or any of its ingredients
  • Have certain heart problems (the trial team can advise you about this)
  • Take other medication that affects body substances called CYP enzymes (the trial team can advise you about this)
  • Have HIV or another medical condition that affects your immune system Open a glossary item
  • Have any other medical or mental health problem that the trial team think could affect you taking part in this trial
  • Are unable to swallow tablets
  • Have a problem with your digestive system Open a glossary item that could affect how you absorb medication
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. The researchers need 145 people to join.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

  • People in one group have olaparib
  • People in the other group have a dummy drug (placebo)

Of the people who join, 3 out of every 5 people will have olaparib and 2 out of every 5 people will have the dummy drug.

Olaparib and the dummy drug are tablets. You take 2 tablets twice a day. You can continue taking them as long as they are helping you and the side effects aren’t too bad.

The trial team will ask you to fill out a questionnaire before you start treatment, every week for 4 weeks, then every 4 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

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

The team will use one of the blood samples to see if you have a certain inherited change (mutation) in BRCA1 or BRCA2. If you don’t have the mutation, you can’t take part in the trial. Your doctor will talk to you about other treatments you can have.

 

Hospital visits

You see the doctor to have some tests before taking part. These tests include

  • A physical examination
  • Blood tests
  • CT scan or an MRI scan
  • Heart trace (ECG) Open a glossary item

During treatment you see the doctor every week for the first 4 weeks and then every 4 weeks for a physical examination and blood tests. You have a CT scan or MRI scan every 8 weeks for 10 months and then every 12 weeks.

A month after finishing treatment you see the doctor for blood tests and to see how you are. If your cancer didn’t get worse while having treatment you see the doctor every 8 weeks for 10 months and then every 12 weeks. If your cancer starts to grow again you have another scan and see the doctor very 8 weeks.

Side effects

The most common side effects of olaparib are

The trial doctor will talk to you about the possible side effects of olaparib before you agree to take part in this trial.

Location

Glasgow
Liverpool
London
Northwood
Scotland
Sutton

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

Professor Daniel Hochhauser

Supported by

AstraZeneca
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Parexel

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13023

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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