Frequently Asked Questions
Zanzalintinib is a type of study drug called a and not considered chemotherapy medicine. Zanzalintinib is a pill that is taken orally (by mouth). TKIs are thought to reduce or stop signals that tell cells to grow, divide, and spread. By blocking these signals, TKIs may slow tumor growth in some types of cancer. Zanzalintinib is a study drug that is not yet approved by the U.S. Food and Drug Administration (FDA), and it is currently being studied as a possible treatment for advanced or metastatic neuroendocrine tumors.
Everolimus is a different type of drug called an , which is given orally (by mouth). mTOR blockers may reduce the growth of cancer cells and blood vessels that support cancer cell growth. Everolimus is approved by the FDA for use alone and in combination with other medicines for many different types of cancer, including neuroendocrine tumors.
A clinical research study is also sometimes called a clinical trial. Research studies are done for many reasons, including to find new ways to treat a disease or condition. A research study helps to answer important questions about a medicine that is still being tested, such as:
- Does it work?
- What amount, or dose, may work best?
- How safe is it?
- Are there side effects?
All medicines must be tested in clinical research studies before they can be approved for the general public. Without people taking part in these studies, we would have no new, approved medicines.
Some possible benefits of taking part in a research study may include:
- Having access to study drug(s) that you cannot receive outside of the study
- Helping researchers learn more about cancer to help people in the future
Clinical research studies should include all kinds of people. Certain conditions and medicines may affect people differently based on their age, sex, race, and ethnicity.
You should know that, even if the study drugs do not work as planned, what is learned may be useful to future participants and researchers. The information learned may help doctors decide how to treat other people with this type of cancer.
Talk to your doctor to find out more about the risks involved with taking part in this trial.
1. Volunteering for a study is a personal choice. If you are eligible to join the study, you will be given an informed consent document. It describes the study and provides important information such as:
- Your rights as a participant
- What taking part in the study will look like for you
- Any potential risks
Study staff will review the full document with you before you sign it and enroll in the research study. The study staff want to make sure that you understand the known risks of the study drugs and that they may or may not work how researchers think they will. Sometimes there are unexpected problems, including serious side effects.
2. Which research study you are eligible for will be decided by the study healthcare team. Clinical research studies are done in a series of steps called “phases.”
Phase 1 studies are small (15 to 30 patients) and determine the safety profile of a study drug, what side effects it has, and if it affects the particular disease or condition.
Phase 2 studies are larger (50 to 100 patients) and are used to determine if the study drug works on a particular disease or condition. Researchers continue to monitor study safety, including side effects.
Phase 3 studies can be much larger (100 to >1000 patients) and compare the study drug to the current standard therapy to see which works better. Safety is carefully tracked to assess side effects. In phase 3 trials, participants are randomly assigned to ensure differences are real and not the result of differences in the people in each group.
Phase 2/3 studies combine the characteristics of both phase 2 and phase 3 studies. If the phase 2 portion of the study shows that the study drug is effective in treating a particular disease or condition, the study progresses to phase 3, which then determines if the study drug works better than the usual treatment for a disease. As with all phases, researchers continually collect data about safety.
Phase 4 studies occur after the study drug has been approved and looks at long-term safety and effectiveness.
3. A healthcare team will take care of you during the study. They will give you specific instructions to follow while you take part in the study. Your healthcare team will also:
- Monitor your health
- Track how you respond to the study drugs
- Change or stop the study drugs if needed or if you are not feeling well
4. Taking part in a research study may involve additional visits and tests. This lets study doctors check how you respond to the study drugs and if there are any safety concerns.
5. There is a risk of side effects. Ask your study doctor for more information.
6. If your tumors continue to grow and you are in Group B, which is taking everolimus, you may be able to cross over, or switch, to Group A and receive the study drug, zanzalintinib.
7. You can choose to leave the study at any time. If you decide to leave the study, your doctor will discuss other treatment options with you.
8. After the study is done, you will be able to see results from the study. Some overall study results will be posted on clinicaltrials.gov. Your personal information will not be shared through this website, but you can get your personal results from your study doctor.
If you are thinking about joining a clinical research study as a treatment option, the best way to start is by talking with the doctor treating your cancer. Your doctor can help you decide if a clinical research study could be a good option for you. To help start that conversation, download the Discussion Guide.
If you decide to take part, you may receive treatment for about 14 months. The length of time in the study may be different for each person and can depend on:
- If the study drug is helping
- If you have any side effects
You will continue to be checked on after you may stop receiving any study drug(s). You can choose to leave the study at any time. If you decide to leave the study, your doctor will discuss other treatment options with you.
Clinical research studies need participants from many different age groups, sexes, races, ethnicities, social/educational/economic backgrounds, life experiences, and more. Having diverse representation in research studies helps show if a new medicine is safe and works for people likely to use it in the future.
Discussion Guide
(Questions for your doctor)
To find out more about participating in the STELLAR-311 study, download the Discussion Guide with questions that can help you and your doctor decide if this study is right for you.
Contact Us
Call Exelixis Medical Information at
ClinicalTrials.gov
Find out more about STELLAR-311 on ClinicalTrials.gov. Search for NCT06943755.
ZANZALINTINIB HAS NOT BEEN APPROVED BY REGULATORY AUTHORITIES. THE SAFETY AND EFFECTIVENESS OF ZANZALITINIB HAVE NOT BEEN ESTABLISHED AND ARE BEING STUDIED AS PART OF THIS CLINICAL TRIAL.