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A Multicenter, Randomized, Double-blind Phase 2 Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer (RR-DTC) to Evaluate Whether an Oral Starting Dose of 20 mg or 14 mg Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile
Eisai Co., Ltd.
This study consists of 2 phases, the Prerandomization Phase and the Randomization Phase. The Prerandomization Phase will last no longer than 28 days and will include a Screening Period to establish protocol eligibility and a Baseline Period to confirm eligibility and establish disease characteristics prior to randomization and treatment.
The Randomization Phase will consist of a Treatment Period and a Follow-up Period. It will begin at the time of randomization of the first participant and will consist of 28-day blinded study treatment cycles. The End of Study will occur at the end of the Randomization Phase, which is defined as when the last participant enrolled completes the Week 24 tumor assessments or discontinues study treatment if before Week 24. Participants will be randomly assigned to treatment with 1 of 3 blinded dosages of lenvatinib in a 1:1:1 ratio to receive lenvatinib 24 mg, 20 mg, or 14 mg orally QD. Dose reductions will occur in succession based on the previous dose level (24, 20, 14, 10, 8, or 4 mg QD). Once the dose has been reduced, it may not be increased at a later date.