NCT05668962
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
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Record History
All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗
- Minor Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2024); last known: Recruiting
- Minor Study sites: 5 to 6v4
- Notable Primary completion date: Mar 1, 2024 to Mar 1, 2025
- Eligibility criteria expanded, about 20 words
- Study sites: 1 to 5
- Study completion date: Jan 1, 2025 to Jan 1, 2026
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Jan 2023 to Mar 1, 2023
- Site details revised
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Objective Response Rate
Timeframe: 6 Months
Secondary (7)
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE v5.0
Rate of restoration of I-131 uptake
thyroglobulin biochemical response rate
Progression Free Survival
Overall Survival
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Time to subsequent systemic treatment
Overall Response Rate-Adolescent
Arms and interventions
SELPERCATINIB + I-131 NaIExperimental
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Participants will be treated with Selpercatinib for 4 weeks. * In the fourth week of treatment, participants will receive a therapeutic dose of I-131 NaI. * Those participants in whom radioiodine uptake has been restored may be offered a second 4-week course of selpercatinib plus I-131 NaI treatment
Drugs: Selpercatinib, Sodium Iodine I-131, rhTSH
Sites
6 sites in 1 country