drugset / Trial / NCT03533361

Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil

NCT03533361

Expanded access Approved for marketing Eisai Inc.

Summary

This is an Expanded Access Program to make lenvatinib available to participants with radioiodine-refractory differentiated thyroid cancer in Brazil. Participants who have no other treatment options available, and who, in the opinion and clinical judgment of the treating physician, would benefit from treatment with lenvatinib will be enrolled. This is a multicenter, open-label program consisting of 2 phases: a 28-day pretreatment phase (including screening) and a treatment phase. Treatment will be provided as long as there is a clinical benefit based on tumor assessments performed according to the center's standard of care and the judgment of the participant's treating physician.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 4 mg Oral
Subject Lenvatinib Small molecule 10 mg Oral

Indications