GEP-NETs Clinical Trial

Disclaimer:

This video is based on public information and is not IRB approved. The images and description in this video do not reflect the opinion of the study sponsor or principal investigators. This is meant for educational purposes, only for the general public.

‍

The ACTION-1 clinical trial is for patients with advanced, low grade, gastroenteropancreatic neuroendocrine tumors or GEP-NETs that have grown after treatment with Lutetium medicine.

‍

In this trial, patients are randomly assigned to receive either a standard of care treatment or RYZ101. RYZ101 is a drug that uses a different radioactive molecule called Actinium. This molecule can cause more damage to cancer cells than Lutetium. 

‍

FAQs:

‍

What specific side effects should patients be aware of when considering RYZ101?

While the video does not detail the specific side effects of RYZ101, patients considering this treatment should be aware that, like other radiotherapies, it may cause fatigue, nausea, low blood counts and potential damage to surrounding healthy tissues, among other side effects. Since RYZ101 is noted to cause more damage to cancer cells than Lutetium, it might also have a unique side effect profile, which researchers will monitor closely during the trial.

‍

Given that RYZ101 uses Actinium, how is it cleared out of the body?

Part of the purpose of this trial is to better understand how RYZ101 is cleared out of the body.  Typically, radiopharmaceuticals are designed to be expelled through the kidneys and bladder.  The trial will monitor for any adverse effects related to the excretion process and implement safety protocols to minimize exposure to the patient's family and others.

Are there any measures in place for patients who do not respond to their assigned treatment, or if they experience significant side effects, can they switch treatments or leave the trial?

The trial protocol includes provisions for alternative treatments or withdrawal from the study. This information would be disclosed in the Informed Consent forms before joining the trial. These measures ensure patient safety and ethical treatment practices. Additionally, the open-label design allows patients and doctors to make informed decisions about continuing with the assigned treatment or considering other options available outside the trial.