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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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