Randomized Phase II Trial of Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)
Washington University School of Medicine
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. * Measura…
Interventions
- DrugLenvatinib
Lenvatinib is an oral drug which will be administered on an outpatient basis at a dose of 24 mg daily or 10 mg daily for an unlimited number of cycles.
Location
- Washington University School of MedicineSt Louis, Missouri