The POLO clinical trial is a Phase 3 study in metastatic pancreatic cancer. The POLO study will investigate whether giving olaparib — a type of investigational medication known as a poly (ADP-ribose) polymerase (PARP) inhibitor — to people with metastatic cancer of the pancreas can help to control the disease between chemotherapy treatments. Metastatic means the cancer has spread from the part of the body where it began to another part of the body.
Olaparib is being investigated as a metastatic pancreatic cancer ‘maintenance therapy’. A maintenance therapy is a medication that is given to people following their initial treatment to further control the cancer and to try to stop it from growing or returning. All people in the POLO study must have received initial platinum-based chemotherapy, which has improved or stabilized their cancer.
To understand whether olaparib helps people with metastatic pancreatic cancer, it will be tested against a ‘sugar pill’ or dummy medication called a ‘placebo’. A placebo does not contain any active medication. In the POLO study, for every five people who take part in the trial, three will receive olaparib and two will receive placebo. It is important to note that at the time of enrollment onto the POLO study, patients should have reached a point in their chemotherapy where both they and their doctor believe that a break from chemotherapy is appropriate.
To be eligible to join the POLO study, you must:
- Be at least 18 years of age
- Have metastatic adenocarcinoma of the pancreas
- Have specific changes (mutations) in your BRCA genes (deleterious germline BRCA mutations). People who do not know their BRCA status must be tested before starting study treatment to make sure they have germline BRCA mutation-positive pancreatic cancer. Your doctor can arrange this test for you when assessing whether you can take part in the trial. If you do not have the BRCA mutation, you will not be able to participate in the study
- Must be receiving your first course of chemotherapy treatment for metastatic disease with a platinum-containing regimen*, and have received the platinum component for a minimum of 16 weeks. If you are no longer receiving the platinum component, the remaining chemotherapy must be continued until you enroll in the trial. Other drugs can be dropped if your doctor recommends this but no new chemotherapy drugs can be added and your last dose of chemotherapy must have been completed 4-8 weeks before you start treatment with the study drug
*Acceptable platinum agents include carboplatin, cisplatin, and oxaliplatin
- There must be no sign that your disease has worsened at any time while you have been receiving your initial course of chemotherapy; your tumor must have stabilized or improved during treatment
- Have reached a point in your chemotherapy where both you and your doctor believe having a pause or break in your chemotherapy treatment is appropriate
- Be willing and able to participate in the study by taking two tablets twice each day by mouth, which may be either the PARP inhibitor, olaparib, or placebo
- Be willing and able to attend regular clinic visits and undergo associated laboratory tests to assess your health status
You will also need to meet other study requirements (assessed by the study doctor or nurse) to be eligible for the POLO study. For further details, please see Can I take part?
If you would like to volunteer for a pancreatic cancer clinical trial, you will need to speak to your doctor. If you join the POLO study, you will need to take two tablets containing the study medication (either olaparib or placebo) twice a day for as long as your study doctor thinks is appropriate. You will need to come into the clinic to undergo various health assessments at the start of the study and at regular intervals to see if your pancreatic cancer is improving, staying the same, or getting any worse. Even if you stop taking the study medication, you will be encouraged to stay in the POLO study so that your progress can be followed. Participating in the follow-up program means that your study doctor will be able to continue to monitor your progress and well-being at regular intervals.
All medicines can have side effects. For olaparib, the most common side effects include:
- Nausea (feeling sick)
- Vomiting (being sick)
- Fatigue (tiredness)
- Anemia (low level of red blood cells)
Myelodysplastic syndrome (blood disorder)/acute myeloid leukemia (blood cancer) and pneumonitis (inflammation in the lungs) have also been found to occur in a small number of patients treated with olaparib. Throughout the study, your doctor will ask you how you are feeling when taking the study medication and you will be asked to complete questionnaires about how you are doing.
Although it is hoped that olaparib treatment will help you, this cannot be guaranteed. The trial is designed to help us find out if olaparib as a treatment for metastatic pancreatic cancer following chemotherapy can help people living with pancreatic cancer at a time when their chemotherapy is paused. Out of every five patients who take part in this study, three will receive olaparib and two will receive placebo. So that people receiving olaparib and those receiving placebo are treated in the same way, it is important that nobody, including you and the doctors and study nurses, know who is taking which treatment (this is known as the study being ‘double-blinded’). Your participation in this study will help scientists to understand whether or not olaparib can help people with metastatic pancreatic cancer and further aid their understanding of the disease. By participating in this study, you will also receive extra monitoring and care for your pancreatic cancer.
AstraZeneca plans to recruit approximately 145 people for the POLO study.
Further information about pancreatic cancer research and advice about participating in pancreatic cancer clinical trials can be found through the links on the Additional information page.