Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
This research study is investigating two different medicines, zanzalintinib and everolimus, for people with advanced neuroendocrine tumours. These are specific types of tumours that start in hormone-producing cells, either in the pancreas (pNET) or other parts of the body (epNET). The main goal is to find out if zanzalintinib works better than everolimus in slowing down or stopping the growth of these tumours in patients who have already received other treatments and whose cancer has progressed. This study is in the later stages of clinical development (Phases 2 and 3), meaning it's an important step toward potentially making these treatments more widely available. Researchers are keen to improve treatment options for this condition, and studies like this help them understand which medicines are most effective and safe.
At a glance
What is this study about?
This study is a clinical trial looking at new and existing treatments for neuroendocrine tumours. These are uncommon cancers that can grow slowly. They start in special cells throughout the body that produce hormones. In this particular study, the focus is on neuroendocrine tumours that have either grown locally to a point where they can't be removed with surgery, or have spread to other parts of the body (metastatic).
The trial is comparing two different medicines: zanzalintinib and everolimus. Everolimus is a treatment that is already available for some neuroendocrine tumours. Zanzalintinib is a newer treatment that researchers want to understand better. The main aim is to see if zanzalintinib is more effective than everolimus in helping patients whose tumours have continued to grow despite previous treatments. This is a vital part of medical research, as it helps doctors find better ways to manage complex conditions.
By comparing these two medicines, doctors hope to gather important information about how well each treatment works, its potential side effects, and ultimately, which offers the best outcome for patients. Such research is crucial for advancing medical care and providing new hope for people living with neuroendocrine tumours.
Key takeaways
- This study compares two treatments for advanced neuroendocrine tumours.
- It aims to find better options for people whose cancer has progressed.
- Participation involves regular clinic visits, scans, and taking study medication.
- You might receive a new treatment (zanzalintinib) or an existing one (everolimus).
- Potential benefits and risks are involved, which will be explained fully.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, your doctor would first check if you meet certain criteria. You would need to have a confirmed diagnosis of a well-differentiated neuroendocrine tumour of a certain type and grade, specifically from the pancreas or other organs, that has either grown locally and can't be removed by surgery, or has spread to other parts of your body. Importantly, your tumour must have shown signs of growth or spread in the last year, as seen on scans like CT or MRI, despite you having already received other treatments.
There are also some conditions that would mean you couldn't take part. For example, if you have certain other types of neuroendocrine cancers or specific mixed cancer types. You also wouldn't be able to join if you've previously been treated with certain other types of targeted therapies (VEGFR or mTOR inhibitors) that work in a similar way to the study drugs.
Additionally, there are time limits regarding other recent treatments. If you've had chemotherapy, certain liver treatments, other ablative therapies, or radiotherapy recently, you might need to wait a specific period before being able to join the study. The medical team will discuss all these details with you during the screening process to make sure the study is right and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do you have a confirmed neuroendocrine tumour diagnosis?
- Has your tumour grown or spread despite previous treatments?
- Have you recently had specific other cancer treatments (e.g., certain targeted therapies, chemotherapy, radiotherapy)?
- Are you willing to provide a tissue sample if needed?
- Are you generally well enough to participate in a clinical trial?
What does participation involve?
If you decide to take part, you would be randomly assigned to receive either zanzalintinib or everolimus. This is like flipping a coin, so neither you nor your doctor can choose which treatment you get. You would have regular visits to the clinic for assessments, which will include physical examinations, blood tests, and scans (like CT or MRI) to monitor your tumour's response and your general health. You would take the study medication as prescribed by the research team. The total duration of your participation in the study would depend on how your tumour responds to the treatment and your overall health, but you would be monitored closely throughout. Specific details about the frequency of visits and tests would be fully explained by the study team.
Potential risks and benefits
Locations (80)
- Exelixis Clinical Site #43Verified postcodeBirmingham, United States· Recruiting
- Exelixis Clinical Site #36Verified postcodePhoenix, United States· Recruiting
- Exelixis Clinical Site #42Verified postcodeTucson, United States· Recruiting
- Exelixis Clinical Site #18Verified postcodeBeverly Hills, United States· Recruiting
- Exelixis Clinical Site #16Verified postcodeLos Angeles, United States· Recruiting
- Exelixis Clinical Site #54Verified postcodePalo Alto, United States· Recruiting
- Exelixis Clinical Site #12Verified postcodeSanta Monica, United States· Recruiting
- Exelixis Clinical Site #29Verified postcodeVallejo, United States· Recruiting
- Exelixis Clinical Site #19Verified postcodeWashington D.C., United States· Recruiting
- Exelixis Clinical Site #35Verified postcodeJacksonville, United States· Recruiting
- Exelixis Clinical Site #11Verified postcodeTampa, United States· Recruiting
- Exelixis Clinical Site #9Verified postcodeLexington, United States· Recruiting
Common questions
What is a neuroendocrine tumour?
It's an uncommon type of cancer that starts in cells that produce hormones throughout the body, often in the gut or pancreas.
What does 'locally advanced or metastatic' mean?
It means the tumour has grown large in one area and cannot be removed by surgery, or it has spread to other parts of the body.
What are zanzalintinib and everolimus?
They are different types of medicines used to treat cancer. Everolimus is already approved, while zanzalintinib is a new drug being tested here.
Will I know which medicine I'm getting?
No, you will be randomly assigned to one of the treatments, similar to drawing lots, so neither you nor the doctors can choose.
Can I stop participating in the study if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Exelixis Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.