Clinical trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer

Name

E7080-G000-303

Description

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).

Trial arms

Trial start

2011-03-17

Estimated PCD

2013-11-15

Trial end

2019-03-19

Status

Completed

Phase

Early phase I

Treatment

Lenvatinib

Lenvatinib 24 mg (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.

Arms:

Lenvatinib (Randomization Phase), Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)

Other names:

Lenvatinib (Lenvima, E7080)

Placebo

Matching placebo (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously.

Arms:

Placebo (Randomization Phase)

Lenvatinib

Lenvatinib 20 mg (two 10-mg capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity. The dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013. Thus, more subjects were treated with 24 mg starting dose and the treatment duration was longer for these participants than those whose starting dose was 20 mg.

Arms:

Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)

Other names:

Lenvatinib (Lenvima, E7080)

Size

392

Primary endpoint

Progression Free Survival (PFS)

Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years

Eligibility criteria

Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of one of the following DTC subtypes: Papillary thyroid cancer (PTC) or follicular thyroid cancer (FTC). 2. Measurable disease according to (RECIST 1.1) and confirmed by central radiographic review. 3. 131 I-refractory/resistant disease. 4. Evidence of disease progression within 12 months prior to signing informed consent (+1 month screening window). 5. Prior treatment with 0 or 1 vascular endothelial growth-factor (VEGF) or vascular endothelial growth-factor receptors (VEGFR) targeted therapy. 6. Adequate renal, liver, bone marrow, and blood coagulation function, as defined in the protocol. Exclusion criteria: 1. Anaplastic or medullary carcinoma of the thyroid 2. 2 or more prior VEGF/ VEGFR-targeted therapies 3. Received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug. Inclusion criteria for OOL Lenvatinib Treatment Period : Participants were eligible for lenvatinib treatment in the OOL Lenvatinib Treatment Period if the met the following criteria: 1. Placebo-treated participants in the Randomization Phase who had progressive disease (PD) confirmed by IIR, and who requested treatment with lenvatinib. 2. Participants who continued to satisfy specified inclusion and exclusion criteria as presented in the study protocol. 3. Participants with maximum interval between the day of confirmation of PD by IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period of less than or equal to 3 months. 4. No systemic anticancer treatment during the interval between the day of confirmation of PD by the IIR and Cycle 1/Day 1 of the OOL Lenvatinib Treatment Period.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 392, 'type': 'ACTUAL'}}

Updated at

2023-06-22

1 organization

2 products

1 indication

Product

Indication

Organization

Product