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

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Trial Identification

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

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

Study ID: NCT02966093

Interventions

Lenvatinib
Placebo

Study Description

Brief 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.

Detailed Description: This study will be conducted in 3 phases: a Prerandomization Phase, a Randomization Phase, and an Extension Phase. The Extension Phase will consist of the Optional Open Label (OOL) Lenvatinib Treatment Period and the Follow-up Period.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

1002 Eisai Trial Site, Beijing, Beijing, China

1006 Eisai Trial Site, Beijing, Beijing, China

1020 Eisai Trial Site, Beijing, Beijing, China

1026 Eisai Trial Site, Beijing, Beijing, China

1025 Eisai Trial Site, Xiamen, Fujian, China

1012 Eisai Trial Site, Lanzhou, Gansu, China

1003 Eisai Trial Site, Guangzhou, Guangdong, China

1027 Eisai Trial Site, Guilin, Guangxi, China

1018 Eisai Trial Site, Zhengzhou, Henan, China

1023 Eisai Trial Site, Wuhan, Hubei, China

1016 Eisai Trial Site, Changsha, Hunan, China

1021 Eisai Trial Site, Changsha, Hunan, China

1008 Eisai Trial Site, Nanjing, Jiangsu, China

1014 Eisai Trial Site, Nanjing, Jiangsu, China

1022 Eisai Trial Site, Changchun, Jilin, China

1015 Eisai Trial Site, Shenyang, Liaoning, China

1004 Eisai Trial Site, Shanghai, Shanghai, China

1017 Eisai Trial Site, Shanghai, Shanghai, China

1019 Eisai Trial Site, Shanghai, Shanghai, China

1011 Eisai Trial Site, Taiyuan, Shanxi, China

1007 Eisai Trial Site, Chengdu, Sichuan, China

1001 Eisai Trial Site, Tianjin, Tianjin, China

1010 Eisai Trial Site, Tianjin, Tianjin, China

1005 Eisai Trial Site, Hangzhou, Zhejiang, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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