A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
(SELECT Trial)

Recruiting in Palo Alto (17 mi)

+154 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eisai Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).

Research Team

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC).

Measurable disease according to (RECIST 1.1) and confirmed by central radiographic review.

131 I-refractory/resistant disease.

See 3 more

Treatment Details

Interventions

Lenvatinib (Tyrosine Kinase Inhibitor)

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)Experimental Treatment1 Intervention

Participants will receive lenvatinib 24 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent. Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.

Group II: Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)Experimental Treatment1 Intervention

Participants will receive lenvatinib 20 mg, orally once daily until documentation of disease progression (confirmed by investigator's assessment), development of unacceptable toxicity, or withdrawal of consent. Placebo treated participants in the Randomization Phase who have progressive disease confirmed by IIR could request to receive lenvatinib treatment in the OOL Treatment Period.

Group III: Lenvatinib (Randomization Phase)Experimental Treatment1 Intervention

Participants randomly assigned in a 2:1 ratio to receive blinded study drug (lenvatinib or matching placebo) until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

Group IV: Placebo (Randomization Phase)Placebo Group1 Intervention