Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC

Status Recruiting

Clinical Trial Summary

This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131) uptake and allow for I-131 treatment in people with RET fusion-positive radioiodine-refractory thyroid cancer. This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH).

Clinical Trial Description

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. - This research study involves the study drug selpercatinib in combination with standard of care treatments, I-131 and thyrotropin alfa (rhTSH). Participants receive study treatment for as long as the disease does not worsen (disease progression) for approximately 1 month for up to two courses of treatment, if participants do not experience any unacceptable side effects, and/or until withdrawal of consent. - Participants will be followed for 2 years from the date of study registration. - It is expected that about 30 people will take part in this research study/ - This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. - The U.S. FDA has approved selpercatinib, I-131 and rhTSH as a treatment option for this disease. - The combination therapy is investigational as it has not been approved to treat this disease. - Selpercatinib, I-131 and rhTSH are standard of care treatment options for thyroid cancer. Selpercatinib is a small molecule designed to block the active RET signaling. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05668962
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Lori J. Wirth, MD
Phone	617-724-1134
Email	lwirth@mgh.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	March 1, 2023
Completion date	January 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.