Polo: BRCAm Pancreatic Cancer
Are you interested in the possibility of a new option for treating your pancreatic cancer? Ask your physician for more information about this clinical research study and to see if you can participate.
What is Pancreatic Cancer?
Pancreatic Cancer begins when abnormal cells in the pancreas grow out of control and form a tumor. The symptoms associated with pancreatic cancer are often vague, similar to symptoms caused by other conditions and may not be present in early stages of the disease.
The importance of Pancreatic Clinical Research Studies
Pancreatic cancer clinical research studies are necessary to determine whether new treatments will be beneficial to people living with pancreatic cancer. The United States Food and Drug Administration (FDA) reviews and analyzes data from successful clinical trials to determine whether an experimental treatment should be approved for a specific disease or disorder, such as pancreatic cancer.
Clinical research studies are the only way that researchers can develop new treatment options for pancreatic cancer. Currently, only about 4.5% of pancreatic cancer patients enroll in clinical trials. Many patients are not aware of this option. Increased patient participation would help with progress in the development of new treatments for the disease. Another benefit of being enrolled in a study is the additional monitoring and care you will receive for your condition.
What is the study about?
This study is being conducted to test a new investigational medicine in people who have been diagnosed with metastatic pancreatic cancer ( a cancer that has spread outside the pancreas) and have a gBRCA genetic mutation. The researchers are trying to determine how effectively the investigational medication controls the disease between chemotherapy treatments.
Who can participate?
You may qualify for this study if you are:
*Male or female 18 years of age and older.
*Clinically diagnosed with metastatic pancreatic cancer.
*Received initial chemotherapy and the disease is stabilized or improved.
*Have a gene mutation in gBRCA1 or gBRCA2.
Other study requirements (assessed by the study doctor and/or nurse) will also need to be met to participate.
Qualifying for the study will depend upon meeting certain criteria. If you think study would be a good fit for you or someone else, please contact your study team for more details.
What would you be expected to do?
If you decide to join this study you could become one of nearly 145 people taking part in more than 80 hospital worldwide.
This study involves taking pills twice daily and regular visits to your study doctor that will last as long as you are benefiting from the treatment and willing to be involved in the study. At these visits your health status will be reviewed and other lab tests performed according to the study requirements.
Participation in this study is completely voluntary. You are free to stop participation at any time and for any reason and your regular health care coverage will not be affected.
If you have a gBRCA mutation, have benefited from your chemotherapy and your doctor and you have decided it is time to take a break from the chemotherapy, meet other study requirements, you will be randomly assigned to receive during this chemotherapy break, either the investigational medication (60% chance) or tablets with no medication (so called placebo) (40% chance). All study-related medication and procedures will be provided at no charge. You may be reimbursed for travel expenses.
Before enrolling in this study, you will be given an Informed Consent Document. This form is designed to explain the purpose of the study and the possible risks and benefits. A member of the study staff and/or study doctor will review and discuss this form with you. If you consent to participate on the study you will sign the Informed Consent Document and will get a copy.
Information About Clinical Research Studies:
It is important that you feel fully informed and comfortable about what to expect if you participate in this clinical research study. The study staff will answer any questions you may have about this clinical research study.
Some clinical research studies are designed to answer specific questions about investigational study medications and some studies are designed to ensure medication that is already being sold is safe and effective. This clinical research study is evaluation the safety and effectiveness of an investigational medication for treating your pancreatic cancer and delaying it from coming back and needing to resume chemotherapy.
Clinical research studies are performed according to strict government and regulatory guidelines. These guidelines help ensure that a participation’s safety and rights are protected during the clinical research study while allowing valuable information about he investigational medication to be collected.
Participation in any clinical research study is completely voluntary and you can withdraw from the study at any time for any reason.
For more information about the study:
If you would like to learn more about this study and to see if you are able to participate, please contact: The Pancreatic Cancer Action Network National Office.
Disclaimer” This information was taken directly from the BRCAm Pancreatic Cancer Center pamphlet and I give them full credit for it. I have never been part of a study here or used the service so I have no opinion on it either good or bad to how it is, so please call the above number for more information.