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A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China

NCT02966093 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2022-01-26

No results posted yet for this study

Summary

The primary purpose of this study is to compare the progression-free survival (PFS) of participants with radioiodine (131 I)-refractory differentiated thyroid cancer (DTC) and radiographic evidence of disease progression within the prior 12 months treated with lenvatinib 24 mg by continuous once daily (QD) oral dosing versus placebo.

Conditions

  • Differentiated Thyroid Cancer (DTC)

Interventions

DRUG

Lenvatinib

Participants will received lenvatinib 24 mg (two 10-mg capsules + one 4-mg capsule) orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.

DRUG

Placebo

Participants will received lenvatinib matched placebo (two 10-mg capsules + one 4-mg capsule) orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2019-07-31
Completion
2021-12-29

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02966093 on ClinicalTrials.gov