NCT05668962

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

Restoration of Radioiodine Uptake with Selpercatinib in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer: a Phase 2 Study Performed in Collaboration with the International Thyroid Oncology Group (ITOG)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to determine the efficacy of selpercatinib to restore radioactive iodine (I-131 NaI) 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).

Detailed 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.

Conditions

• Thyroid Cancer
• Thyroid Carcinoma
• Metastatic Thyroid Cancer
• Follicular Thyroid Cancer
• Unresectable Thyroid Gland Carcinoma
• Papillary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Selpercatinib	Selpercatinib Oral, twice daily during initial treatment period (28 Days). A second course of selpercatinib if the participant is demonstrating clinical benefit to the initial course selpercatinib and deemed clinically appropriate by the treating investigator
DRUG	Sodium Iodine I-131	I-131 NaI, oral, is a standard treatment for all types of follicular-derived thyroid cancers, except anaplastic thyroid cancer
DRUG	rhTSH	RhTSH injection, dosage per protocol, timing per protocol during the initial treatment period per standard of care. Participants may receive a second course of rhTSH if the participant is demonstrating clinical benefit to the initial course rhTSH and deemed clinically appropriate by the treating investigator.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-03-01
• Completion: 2026-01-01
• First posted: 2022-12-30
• Last updated: 2024-12-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study