Pancrea c cancer POLO study Recrui ng now AstraZeneca is looking for people with BRCA-mutated metasta c pancrea c cancer to join POLO, a clinical study to help scien sts find be er treatments for this disease Could you help by joining this study? What is a clinical study? A clinical study (or trial) is a scien c inves a on of possible new medica ons, or different versions or new uses of exis ng medica ons. Clinical studies can help to find out whether a poten al new medicine works against a par cular kind of disease. Each study is highly regulated and approved by regulatory and ethical groups before it can begin. In 1 year, an es mated 2.3 million pa ents took part in such carefully conducted trials in the USA. Systems are in place to ensure your personal and medical data are protected. New medica ons must go through several phases of clinical tes ng to determine how well they work and how safe they are; the POLO study is a Phase 3 trial in metasta c pancrea c cancer, which means it is a large-scale trial that is being conducted following ini posi ve results in smaller-scale studies. Clinical studies are the only way that researchers can develop new treatment op ons for people living with pancrea c cancer. Many people are not aware of this op on currently only about 4.5% of all pa ents with pancrea c cancer enroll in clinical trials. Increased par cipa on would help with progress in the development of new treatments for pancrea c cancer.
What is the POLO study? The POLO study will investigate whether giving olaparib a type of medication known as a poly (ADP-ribose) polymerase (PARP) inhibitor to people with metastatic pancreatic cancer who have certain deleterious germline mutations in their BRCA1 or BRCA2 genes, can help stop the cancer from getting worse or coming back and help them live longer. Everyone taking part in the study must have already received one course of platinum-based chemotherapy for a minimum of 16 weeks, and their tumors must have stabilized or improved during this course of chemotherapy treatment. Platinum agents include carboplatin, cisplatin, and oxaliplatin. Enrollment in the POLO clinical study should occur when both you and your doctor believe that it is appropriate to pause or take a break from your chemotherapy, although testing for a germline BRCA mutation can occur at any time. To understand whether olaparib works in people with pancreatic cancer, it will be tested against a dummy medication called a placebo which looks exactly like the study medication but does not contain any active ingredients. A computer decides whether people joining the study will be given either olaparib or placebo (a process called randomization ). In the POLO study, for every five people who take part in the trial, three will receive olaparib and two will receive placebo. So that we are sure that people receiving olaparib and those receiving placebo are treated in the same way, it is important that nobody, including the patients taking part in the study, their doctors, and the study nurses, knows who is taking which treatment (this is known as the study being double-blinded ). The POLO study is for people with a type of pancreatic cancer known as adenocarcinoma, that has spread outside the pancreas (also known as metastatic pancreatic cancer), who have certain changes in their BRCA1 or BRCA2 genes (called mutations).
What is olaparib? Olaparib is an investigational medicine that is different from chemotherapy. Olaparib has been approved by the Food and Drug Administration (FDA) for the treatment of women with germline BRCA genetic mutations with advanced ovarian cancer, who have previously received three or more courses of chemotherapy. Olaparib is a PARP inhibitor which means it works by stopping a protein called PARP from working properly. PARP is a new target in pancreatic cancer research. In cancer cells, PARP repairs the DNA of genes that have been damaged by chemotherapy, allowing the cancer cells to multiply and the tumor to get bigger. Since olaparib stops PARP from working, the DNA repair can no longer take place and the cancer might stop growing (stabilize) or shrink (improve) if the treatment works. Why is BRCA important? A gene is a section of DNA carrying information that is transferred from one generation to the next. Changes in some genes, known as mutations, can be linked with certain hereditary diseases. The BRCA genes are implicated in some breast and ovarian cancers. In addition, BRCA mutations have been associated with other cancer types, including pancreatic cancer. People with BRCA mutations have a 1 7% risk of developing pancreatic cancer during their lifetime. A previous small clinical study in pancreatic cancer has shown that olaparib worked in people with mutations in their BRCA1 or BRCA2. One of the aims of the POLO study is to try to confirm these results in a larger group of people who have BRCA mutations. Almost one in every 20 people with pancreatic cancer has changes in their BRCA genes. Some people with pancreatic cancer will already know whether they have these changes, but others may not. Everyone in the POLO study will have their BRCA status tested, even people who have already been tested before. The test is straightforward and requires a small blood sample. Because changes in the BRCA genes tend to run in families, if you do not know your BRCA status, you should discuss testing with your doctor or a genetics expert to understand the conversations you may want to have with family members if the test is positive.
What does the study involve? If you would like to volunteer for the POLO study, you will need to speak to your doctor. If you join the study, you will need to take two tablets containing the study medication (either olaparib or placebo) twice a day for as long as your doctor thinks is appropriate. At the start of the study, you will need to come into the clinic for assessments, including blood tests and scans, to check on your general health and well-being. You will then need to return to the clinic regularly for further assessments to see if your pancreatic cancer is improving, staying the same, or getting any worse. You will also need to fill in two straightforward questionnaires about your health at each clinic visit. While you are taking the study medication, you will need to visit the clinic at least every month. If your cancer gets worse, you will stop taking the study medication. Even if you stop the study medication, you will be encouraged to stay in the POLO study, on the follow-up program. Participating in the follow-up program means that your study doctor will continue to monitor your progress and well-being at regular intervals. Will there be side effects? 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.
How might I benefit? Although it is hoped that olaparib treatment will help you, this cannot be guaranteed, and two-fifths of patients in this study will receive the placebo tablet, not olaparib. However, your participation in this study will help scientists to further understand pancreatic cancer and whether or not olaparib can help other people in your situation. By participating in this study, you will also receive extra monitoring and care for your pancreatic cancer. Could I take part? To be able to take part in the POLO study, amongst other things, you must: Be at least 18 years of age Have been clinically diagnosed with a type of pancreatic cancer known as adenocarcinoma that has spread (also known as metastatic pancreatic cancer) Have an inherited germline BRCA genetic mutation (gbrca1 or gbrca2) Have received one course (minimum of 16 weeks) of platinum-based chemotherapy (e.g. carboplatin, cisplatin, or oxaliplatin), with the last dose completed 4 8 weeks before starting the study treatment Have a tumor that has not grown (stabilized) or shrunk/disappeared (improved) during treatment with platinum-based chemotherapy 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 You must also meet other study requirements (assessed by the study doctor or nurse) to be eligible for the POLO study.
What if I want to take part? If you are interested in taking part, you will need to speak to your doctor about the POLO study. If your doctor thinks you are potentially suitable, they should contact the nearest participating hospital to discuss if you can be invited for a clinic visit to make sure you fully meet the requirements to join the study. Please ask your doctor to look at the information on this website: www.pancreaticcancertrial.com. Alternatively, you can download the document in the Information for healthcare professionals section of the website to give to your doctor: www.pancreaticcancertrial.com/additional-information. Is there anything else I need to know? Participation in the POLO study is entirely voluntary. If you decide not to join the study, you do not need to give a reason and this will not affect the care you receive from your doctor. If you decide to take part but change your mind, you can withdraw from the treatment or study at any time; your regular healthcare will not be affected.
Further information Further information about the POLO study can be found on the POLO study website: www.pancreaticcancertrial.com. If you are in the USA or Canada, you or your doctor can call the AstraZeneca Cancer Study Locator service toll free on 1-877-400-4656 to get more information about the POLO study, to see if you may qualify for this study, and to find a study doctor near you. Alternatively, you can email: astrazeneca@emergingmed.com If you are outside those countries, please talk to your doctor about the POLO study and direct them to the information on the POLO study website: www.pancreaticcancertrial.com.