Conditions: Hepatocellular Carcinoma
Keywords: liver cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 399
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment \[MEE\] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.

Detailed description:

Arms:
arm 1: 8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. arm 2: Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. arm 3: 8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. arm 4: 8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. arm 5: Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

Interventions: intervention 1: Ramucirumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV

Protocol document:
Prot_000.pdf: 
I4T-MC-JVDE Protocol (c)  
 
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best 
Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With 
Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line 
Therapy With Sorafenib 
 
NCT02435433 
 
Approval Date:  24-Apr-2017 


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SAP_001.pdf: 
I4T-MC-JVDE Statistical Analysis Plan 
 
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best 
Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With 
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NCT02435433 
 
Approval Date:  21-Dec-2017 


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