A phase 3 trial looking at olaparib for pancreatic cancer that has spread in people with a BRCA genetic mutation (POLO)
Full title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based chemotherapy
Why is this trial being carried out?
Pancreatic cancer that has spread from the pancreas to other parts of the body is called advanced or metastatic pancreatic cancer. People with advanced pancreatic cancer are usually offered chemotherapy, which can slow down the growth of the cancer.
Faults (mutations) in the BRCA1 and BRCA2 genes increase the risk of developing breast and ovarian cancer. Faults in the BRCA2 gene slightly increase the risk of pancreatic cancer. In this trial researchers want to see if a cancer drug called olaparib is effective in treating people with pancreatic cancer who have a fault in the BRCA genes. Olaparib is currently used to treat women with ovarian cancer caused by a fault in the BRCA genes. Read more about faults in genes, including BRCA genes, and the risk of pancreatic cancer.
Olaparib is a type of drug called a PARP-1 inhibitor. It is taken as a tablet. It stops an enzyme called PARP-1 from working. The enzyme is used by both healthy and cancer cells to repair DNA damage. Researchers hope that if they can stop the PARP-1 enzyme working, the cancer cells will no longer be able to repair themselves and will die.
Researchers want to find out if olaparib stops pancreatic cancer getting worse during a break from chemotherapy. They also want to learn more about the side effects of olaparib, how safe it is and how it improves a person’s daily life.
This is a placebo controlled trial. This means that people who take part will either receive olaparib or a dummy drug (placebo).
Who is the trial suitable for?
The POLO trial may be suitable for you if you:
- have a type of pancreatic cancer called an adenocarcinoma that has spread to another part of your body
- have a certain type of fault in a BRCA gene – this might already be known, or it might be assessed as part of the tests before starting the trial
- have pancreatic cancer that has not continued to grow after chemotherapy that included taking a platinum-containing drug for at least 16 weeks - ask the trial team about this
- have finished previous treatments for at least four weeks and no more than eight weeks before entering the studyhave had a scan that shows that the cancer is not getting worse.
It is not suitable for you if you:
- have pancreatic cancer that has continued to grow after receiving platinum based chemotherapy
- have already had olaparib or another PARP inhibitor
- have certain heart problems – ask the trial team about this
- still have side effects from previous treatment, apart from hair loss and mild to moderate peripheral neuropathy (numbness and tingling in the hands and feet)
- have acute myeloid leukaemia or myelodysplastic syndrome - a blood disorder that causes a drop in the number of your healthy blood cells
- have HIV or another medical condition that affects your immune system
- have had a bone marrow transplant from a donor
- have had a blood transfusion in the past four months – although if the transfusion was only red blood cells or platelets, you may be able to join the trial.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial may be suitable for you.
Recruitment start date: December 2014
Recruitment end date: May 2018
Published April 2016
Review date May 2018
The POLO trial is an international study. In the UK, recruitment is being carried out at:
- Guy’s and St Thomas’ NHS Trust, London
- University College London Hospital (UCLH), London
- The Royal Marsden Hospital (RMH), Sutton/Surrey and Chelsea/London
- Mount Vernon Cancer Centre, Northwood/Middlesex
- Clatterbridge Cancer Centre, Bebington/Wirral (near Liverpool)
- The Christie NHS Foundation Trust, Manchester
- Beatson West of Scotland Cancer Centre, Glasgow, Scotland
- Edinburgh Cancer Centre, Edinburgh/Fife/Dumfries, Scotland
Professor Daniel Hochhauser, University College London (trial lead in the UK)
You can contact the trial centres here:
- University College London Hospital, London: Daniel Hochhauser: email@example.com
- Royal Marsden Hospital (RMH), Sutton/Surrey & Chelsea/London: firstname.lastname@example.org
- Mount Vernon Cancer Centre, Northwood/Middlesex: Dr Mark Harrison, Tel: 01923 844398
- Beatson West of Scotland Cancer Centre, Glasgow, Scotland: Professor Jeff Evans: Jeff.Evans@ggc.scot.nhs.uk
- Edinburgh Cancer Centre, Edinburgh, Scotland: Dr Lucy Wall, Tel: 0131 537 1000
- Guy’s Hospital, Guys & St Thomas’ NHS Trust, London
- Clatterbridge Cancer Centre
- Christie NHS Foundation Trust
If you are interested in taking part in this trial at Guy’s Hospital, Clatterbridge Cancer Centre or the Christie NHS Foundation Trust, speak to your consultant about whether the trial is suitable for you. If it is suitable, they can refer you to take part in the trial at these centres.
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial please visit the Clinicaltrials.gov website.
For references used to develop this information please email us.