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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


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

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