Possibia

5668962

Last Update Posted: 2024-12-12

Recruiting

All Genders

accepted

12 Years +

30 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

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

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).

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.

Eligibility

Relevant conditions:

Thyroid Cancer

Thyroid Carcinoma

Metastatic Thyroid Cancer

Follicular Thyroid Cancer

Unresectable Thyroid Gland Carcinoma

Papillary Thyroid Cancer

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

Lori J. Wirth, MD

lwirth@mgh.harvard.edu

617-724-1134

Data sourced from ClinicalTrials.gov