NCT07092514 Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)
| NCT ID | NCT07092514 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Washington University School of Medicine |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2029-04-17 |
Trial Parameters
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Brief Summary
This open-label, randomized phase II trial evaluates the dose delivery, tolerance, and efficacy of two dosing regimens of lenvatinib among patients with radioactive iodine resistant (RAIR) differentiated thyroid cancer (DTC).
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed DTC, defined as papillary, follicular, or Hurthle Cell thyroid cancer. Papillary has several sub-types such as tall-cell and columnar cell, which are all allowed. * Patient must have incurable RAIR DTC, defined as disease not amenable to cure by surgery AND meeting one or more of the following criteria: * one or more sites of disease that do not take up RAI. * disease progression on RAI (given within the last 12 months). * receipt of cumulative dose of RAI of ≥ 600mCi. * patient declines or is ineligible for surgery and/or RAI. * Measurable or evaluable disease per RECIST 1.1. * No more than 1 prior line of VEGF/VEGFR targeted therapy for DTC. Examples of VEGF/VEGFR therapies include sorafenib, pazopanib, vandetinib, axitinib, sunitinib, and cabozantinib, but others exist. * Symptomatic (defined by usual standard of care clinical criteria) or progressive disease on most recent prior treatment (ex: surgery, RAI, or TKI/targeted therapy) by
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