If you have a BRAF-altered advanced solid tumor which is not responding to current treatments, this study may be an option for you
Alterations in a gene called BRAF can increase the growth and spread of cancer cells. This study is intended to learn about the safety and effects of study medicine PF-07799933, which is designed to block the effects of BRAF protein. The aim is to stop your cancer from growing or make it responsive to other treatments. Some participants will also receive another standard anti-cancer treatment to see if it might be more effective when given with PF-07799933.
Who may participate
Joining a clinical study is an important and personal decision. Thank you for considering the C4761001 study.
This study is recruiting people with advanced solid tumors (cancer that has grown or spread to areas of the body it did not start in), with known BRAF alterations, which available treatments are no longer effective in controlling.
Condition
Advanced solid tumors with BRAF alterations
Age
18 years and older
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
The length of your participation in the study depends on how well you tolerate the study medicine and how your cancer responds, it could be about 2 years.
In addition to taking the study medicine, you will be asked to visit the clinic for health checks. These include health questions, physical examinations, blood and urine samples, tests of your heart function, and imaging scans. These assessments will help us to monitor your safety and well-being, and to see how your cancer is responding.
After you finish receiving the study treatment, you will be contacted every 3 months to check your health status and if you are receiving any other anti-cancer treatments.
Length of study treatment
21 days per dosing cycle
Number of study visits
About 6 visits in the first 2 weeks, then about 2 visits every 3 weeks
Long-term follow up
Every 12 weeks until the study finishes, or you no longer want to be contacted
Frequently Asked Questions
Advanced cancers are those which have grown or spread to areas of the body they did not start in (metastasized). Solid tumors are any type of cancer apart from those of the blood or lymphatic system.
The BRAF gene makes a protein which is involved in the growth of cells in your body. Genetic mutations or other changes to this gene are called BRAF alterations, some of these alterations are found in cancers and cause them to grow. BRAF alterations can stop some anti-cancer treatments from working.
The study medicine is thought to work by blocking the effects of the BRAF protein so that it does not cause cancers to grow.
Informed consent is one of the most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the study.
During the informed consent discussion, you will be given all details about the study, including potential benefits and risks of taking part. You will also be given a document summarizing this information, which you will sign to confirm that you would like to take part in the clinical study.
Yes, participation in clinical studies is completely voluntary: taking part in a study is your choice. You are free to stop being in this study at any time and for any reason and it will not affect your future medical care in any way.
Clinical studies are important to understand more about potential treatment options for all sorts of conditions. Clinical research studies also help us learn more about the side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.
Your health information and any data that could be used to identify you (such as immigration status) will be kept private and safe. Only information that relates to the study will be collected, and only your study team, study doctor, and organizations that oversee the study will be able to access it. Your personal information won’t be shared with third parties such as the government or advertisers.
