A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China
- Conditions
- Differentiated Thyroid Cancer (DTC)
- Interventions
- Drug: Placebo
- Registration Number
- NCT02966093
- Lead Sponsor
- Eisai Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo In the randomization phase, participants will receive lenvatinib matched placebo until disease progression. Participants who discontinue due to confirmed disease progression will enter Extension Phase. Participants who discontinue without confirmed disease progression will be followed for tumor assessment until confirmed disease progression or initiation of anticancer therapy, at which time the participants will enter Follow-up period of Extension Phase. Lenvatinib Lenvatinib In the randomization phase, participants will receive lenvatinib until disease progression. Participants who discontinue due to confirmed disease progression will enter Extension Phase. Participants who discontinue without confirmed disease progression will be followed for tumor assessment until confirmed disease progression or initiation of anticancer therapy, at which time the participants will enter Follow-up period of Extension Phase. Placebo Lenvatinib In the randomization phase, participants will receive lenvatinib matched placebo until disease progression. Participants who discontinue due to confirmed disease progression will enter Extension Phase. Participants who discontinue without confirmed disease progression will be followed for tumor assessment until confirmed disease progression or initiation of anticancer therapy, at which time the participants will enter Follow-up period of Extension Phase.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 12 months PFS is defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurs first) as determined by blinded independent imaging review (IIR) conducted by the imaging core laboratory using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression, per RECIST v1.1, is defined as at least a 20% relative increase and 5 millimeter (mm) absolute increase in the sum of the diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started, or the appearance of 1 or more new lesions.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) From date of first dose of study drug until date of death from any cause or up to approximately 36 months OS is measured from the date of randomization until the date of death from any cause. Participants who are lost to follow-up and participants who are alive at the date of data cut-off will be censored at the date the participants were last known to be alive.
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) For each participant, from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug or up to resolution of adverse event or up to study completion or up to approximately 36 months An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs are defined as AEs that start/increase in severity on/after the first dose of study drug up to 30 days after the final dose of study drug. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Overall response rate (ORR) From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 36 months ORR is the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Trial Locations
- Locations (24)
1025 Eisai Trial Site
🇨🇳Xiamen, Fujian, China
1003 Eisai Trial Site
🇨🇳Guangzhou, Guangdong, China
1006 Eisai Trial Site
🇨🇳Beijing, Beijing, China
1012 Eisai Trial Site
🇨🇳Lanzhou, Gansu, China
1027 Eisai Trial Site
🇨🇳Guilin, Guangxi, China
1014 Eisai Trial Site
🇨🇳Nanjing, Jiangsu, China
1019 Eisai Trial Site
🇨🇳Shanghai, Shanghai, China
1018 Eisai Trial Site
🇨🇳Zhengzhou, Henan, China
1002 Eisai Trial Site
🇨🇳Beijing, Beijing, China
1020 Eisai Trial Site
🇨🇳Beijing, Beijing, China
1026 Eisai Trial Site
🇨🇳Beijing, Beijing, China
1021 Eisai Trial Site
🇨🇳Changsha, Hunan, China
1008 Eisai Trial Site
🇨🇳Nanjing, Jiangsu, China
1015 Eisai Trial Site
🇨🇳Shenyang, Liaoning, China
1016 Eisai Trial Site
🇨🇳Changsha, Hunan, China
1022 Eisai Trial Site
🇨🇳Changchun, Jilin, China
1004 Eisai Trial Site
🇨🇳Shanghai, Shanghai, China
1001 Eisai Trial Site
🇨🇳Tianjin, Tianjin, China
1017 Eisai Trial Site
🇨🇳Shanghai, Shanghai, China
1023 Eisai Trial Site
🇨🇳Wuhan, Hubei, China
1007 Eisai Trial Site
🇨🇳Chengdu, Sichuan, China
1005 Eisai Trial Site
🇨🇳Hangzhou, Zhejiang, China
1011 Eisai Trial Site
🇨🇳Taiyuan, Shanxi, China
1010 Eisai Trial Site
🇨🇳Tianjin, Tianjin, China