Overview

A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safe

Status:
Completed

Trial end date:
2020-09-08

Target enrollment:

Participant gender:

Summary

This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

Phase:

Phase 2

Details

Lead Sponsor:

Eisai Inc.

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Iodine
Lenvatinib