Alterations in a gene called BRAF can increase the growth and spread of cancer cells. This clinical trial is meant to learn about the safety of a study medicine (PF-07799933) and whether the study medicine can stop BRAF-altered advanced solid tumors from growing or make the tumors responsive to other treatments.
As you take the time to consider the next step for your cancer treatment, thank you for learning more about this clinical trial. Participants will receive attentive care from a skilled team of healthcare providers and could help in the discovery of a potential breakthrough medicine for people with BRAF-altered advanced solid tumors.
Who may participate
Joining a clinical trial is an important and personal decision. Thank you for considering this solid tumor clinical trial.
This trial is recruiting people with advanced solid tumors with known BRAF alterations that available treatments are no longer effective in controlling. 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.
Condition
Advanced solid tumors with BRAF alterations
Age
16 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
If you choose to participate, you will review and sign the informed consent document. Then you will visit the study doctor’s office to continue with the screening period to confirm you meet all the eligibility criteria and are able to participate in the trial.
The length of your participation in the trial depends on how well you tolerate the study medicine, how your cancer responds and your personal choice but is expected to last around 2 years. All participants will take the study medicine as a tablet by mouth. There is no placebo used in this study.
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.
Length of clinical trial treatment
Depends on how you tolerate the treatment, how your cancer responds, and your personal choice
Number of study visits
About 5 visits in the first 6 weeks, then about 1 visit every 3 weeks
Long-term follow up
Every 12 weeks until the study finishes, or you no longer want to be contacted
About the study medicine
The BRAF gene makes a protein which is involved in the growth of cells in your body. Under normal conditions, this is a healthy part of your body’s growth and development. Genetic mutations or other changes to this gene are called BRAF alterations. Alterations in the BRAF gene can make it work abnormally and lead to the growth and spread of cancer cells. BRAF alterations can also stop some anti-cancer treatments from working.
The study medicine is thought to work by blocking the effects of the BRAF protein in BRAF-altered cancers so that it does not cause cancers to grow.
Be Represented
BRAF-altered advanced solid tumors impact people across races and ethnicities. Multiple factors, including race, ethnicity, age, and sex can all impact how different people respond to the same treatment. That is why it is important that people of all backgrounds are included in clinical trials.
When you participate in a trial, you’re helping to represent both your community and all people who are affected by advanced or metastatic solid tumors. Your participation could make a difference for yourself and others.
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. Under normal conditions, this is a healthy part of your body’s growth and development. Genetic mutations or other changes to this gene are called BRAF alterations. Alterations in the BRAF gene can make it work abnormally and lead to the growth and spread of cancer cells. BRAF alterations can also stop some anti-cancer treatments from working.
Yes. All participants will receive the study medicine. There is no placebo in this study.
The study medicine is thought to work by blocking the effects of the BRAF protein in BRAF-altered cancers so that it does not cause cancers to grow.
The study medicine is taken as a tablet by mouth. In this clinical trial you will take it once per day. You will be given a supply of the study medicine to take at home.
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 clinical trial.
During the informed consent discussion, you will be given all details about the trial, 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 trial.
Yes, participation in clinical trials 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.
You may be reimbursed for any reasonable expenses that you may have as a result of taking part in this study. This may include parking, meals, or other travel-related expenses.
Clinical trials 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.
