NCT04321954

Lenvatinib in Locally Advanced Invasive Thyroid Cancer

A Phase 2 Study of Neoadjuvant Lenvatinib in Locally Advanced Invasive Thyroid Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to evaluate the safety and efficacy of neoadjuvant lenvatinib on surgical outcomes of patients with invasive extrathyroidal differentiated thyroid cancer (DTC). This research study involves a study drug called lenvatinib

Detailed description

This is a multicenter, phase II, open-label study examining the effect of neoadjuvant lenvatinib being given to patients with extrathyroidal differentiated thyroid cancer (DTC) prior to surgery to remove cancerous tumors (thyroidectomy). \- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * This research study involves a study drug called lenvatinib. * It is anticipated that 30 people will participate in the study. The U.S. Food and Drug Administration (FDA) has not approved lenvatinib for the specific disease of extrathyroidal differentiated thyroid cancer (DTC) but it has been approved for other uses. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

Conditions

• Differentiated Thyroid Cancer
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	LENVATINIB	Orally

Timeline

• Start date: 2021-03-09
• Primary completion: 2025-05-27
• Completion: 2026-05-27
• First posted: 2020-03-25
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study