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PanCAN recently hosted a webinar titled “Clinical Trials: At the Leading Edge of Progress.” Our panel had a wide-ranging conversation that touched on the latest research, new developments in the field as well as some of the most important things patients and families should be thinking about when considering clinical trials. The PanCAN community showed up with so many questions that we couldn’t get to all of them during the webinar!
Here, we follow up and dive more deeply into areas of interest.
How safe are Phase I clinical trials?
Phase I clinical trials are the first step in testing a new treatment or combination of treatments. These trials often involve drugs that have not yet been given to humans but have shown promise in the laboratory. Phase I trials usually enroll a small group of participants, around 20 to 40 people. The goal of these trials is to determine safety, the right dosage and to learn how the treatment is processed inside the body. Often, eligibility requirements related to previous treatments are less strict in Phase I trials, allowing patients who have already had multiple treatments to participate. Every clinical trial conducted in the United States is regulated by the U.S. Food and Drug Administration to protect participants and the public. Safety is closely monitored, and doctors track participants’ health throughout the trial.
There are three phases to the FDA approval process. Only if the treatment proves to be safe and promising at each phase is it allowed to proceed to the next phase of testing. Read more about how drugs receive FDA approval.
What is a biomarker test? Why is it important?
All cancers, including cancers of the pancreas, begin with a mutation in the DNA of one cell causing the cell to grow and divide unchecked. Biomarker testing of a tumor, also referred to as molecular profiling, looks for tumor-specific mutations that we know of. The goal for biomarker testing, along with genetic testing for inherited mutations, is to find a treatment that targets the mutation leading to the cancer, an approach known as precision medicine.
PanCAN strongly recommends that all pancreatic cancer patients get biomarker testing of their tumor tissue and genetic testing for inherited mutations as soon as possible after diagnosis to help determine the best treatment options, including clinical trials.
Biomarker and genetic testing for every patient diagnosed with pancreatic cancer is critical, especially as the number of clinical trials testing treatments targeting specific mutations continues to increase.
Are there therapies targeting KRAS mutations being studied in clinical trials? If so, where?
Yes, there are a number of clinical trials all across the country focused on KRAS and pancreatic cancer – from Phase I studies testing safety and dosage all the way to a Phase III trial comparing an experimental treatment to the standard of care. It’s a rapidly evolving space with new trials coming online and/or closing to enrollment. The best way to understand your current options is to contact PanCAN Patient Services.
About 90% of pancreatic tumors have a KRAS mutation. This information is learned by biomarker testing of tumor tissue. Because KRAS mutations are so common and seem to drive certain cancers, researchers have been working to create medications that can turn off the mutated KRAS proteins. These new medications may target different KRAS mutation subtypes (like G12C, G12R, G12D, etc) or attempt to target multiple kinds of RAS mutations at once.
Does participation in a clinical trial require the patient to stop current treatment in order to participate? If yes, how long is required for a patient to stop current treatment?
Every clinical trial has different eligibility criteria. Treatment history will be considered as part of the enrollment process. Although rarer, some trials may allow you to continue your current treatment, while most trials may require you to stop. It’s important to talk to your healthcare team early and often about your goals for care. Clinical trials are an important option at every point in the treatment journey – at diagnosis and at every decision point along the way.
If you enroll in a clinical trial that requires you to stop current treatment, you may have to wait a few weeks for the previous treatment to flush out of your body. This is called a wash-out period. Additionally, the trial site might require extra tests to confirm your eligibility, which will take time. It’s crucial to communicate early and regularly with the trial sites you’re interested in to ensure a smooth transition.
Are there any clinical trials for relatives of patients (living or decreased) to better study and understand the role genetics may play in pancreatic cancer?
Clinical trials typically focus on evaluating new treatments for patients already diagnosed with a disease. However, some trials are designed to improve early detection—especially for individuals at higher risk, such as relatives of pancreatic cancer patients. In addition to these early detection studies, surveillance programs and registries are available, often involving regular testing for those who qualify. For a personalized clinical trials search or more information about surveillance programs and genetic registries, please contact PanCAN Patient Services.
The risk of developing pancreatic cancer may be higher if someone has:
- One or more first-degree relatives (parent, child, sibling) who have had the disease.
- A first-degree relative who developed pancreatic cancer before the age of 50
- An associated inherited genetic disorder or syndrome.
PanCAN Patient Services can help you understand studies – including genetic registries or surveillance programs – you may be eligible for.
I’m not sure my loved one’s doctor has the time and capacity to find clinical trials. What are my options?
First, be sure to communicate your interest in clinical trials with your loved one’s doctor. Communicating early and often can help you all be on the same page, aligned with your loved one’s goals of care and treatment plans.
Your loved one’s doctor may not be aware of the hundreds of clinical trials that are available throughout the United States. In many cases, they may only know about trials taking place at their institution or at neighboring institutions.
We provide patients with clinical trials search results so that they can explore and discuss all their treatment options with the healthcare team. We can also provide resources to help you have a conversation with your doctor about clinical trials. Download our “Three Steps to Navigate Clinical Trials” to help start the conversation. And contact PanCAN Patient Services for a personalized clinical trials search or explore your options with our Clinical Trial Finder.
