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)
Sponsor: Massachusetts General Hospital + Eli Lilly and Company
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate
Time frame: 6 Months
Secondary Endpoints
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE v5.0
Rate of restoration of I-131 uptake
thyroglobulin biochemical response rate
Eligibility Criteria
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. * …
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