Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC (NCT05668962) | Clinical Trial Compass
RecruitingPhase 2
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
United States30 participantsStarted 2023-03-01
Plain-language 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).
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Participants must have histologically- or cytologically-confirmed follicular-derived nonanaplastic thyroid cancer that is metastatic and/or unresectable AND harbors a known oncogenic RET gene fusion, performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited diagnostic laboratory.
* Tumor tissue or liquid biopsy-based next-generation sequencing (NGS), quantitative polymerase chain reaction (qPCR), and fluorescence in situ hybridization (FISH) for RET gene fusion detection will be permitted.
* Participants ≥ 18 years of age must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
\-- Participants 12 to \<18 years of age may enroll with either evaluable (i.e. anatomically visible tumor on cross sectional imaging, but tumors do not need to be \>1 cm) or measurable disease per RECIST v1.1.
* Participants should have no single tumor deposit exceeding 4.0 cm in the greatest dimension.
* Participants must have RAI-refractory disease, as defined by:
* The malignant tissue does not concentrate RAI on a whole body scan following radioiodine administration
* The tumor tissue has lost the ability to concentrate RAI on a whole body scan following radioiodine administration after previous evidence of uptake at any earlier timepoint,
* RAI is taken up in some but not all tumor deposits on a whole body scan following radioiodine administration and/or
* There is progressive disea…