A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT01761266|
Recruitment Status : Active, not recruiting
First Posted : January 4, 2013
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma (HCC)||Drug: Lenvatinib Drug: Sorafenib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||954 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma|
|Actual Study Start Date :||March 14, 2013|
|Primary Completion Date :||November 13, 2016|
|Estimated Study Completion Date :||March 2019|
|Active Comparator: Lenvatinib||
Lenvatinib: 12 mg (or 8 mg) once daily (QD) oral dosing
Other Name: E7080, Lenvima
|Active Comparator: Sorafenib||
Sorafenib: 400 mg twice daily (BID) oral dosing
- Overall survival (OS) [ Time Frame: From date of randomization until date of death from any cause ]Subjects who are lost to follow-up will be censored at the last date the subject was known to be alive, and subjects who remain alive will be censored at the time of data cutoff.
- Progression-free survival (PFS) [ Time Frame: From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurs first ]
- Time to progression (TTP) [ Time Frame: The time from the date of randomization to the date of first documentation of disease progression ]
- Objective Response Rate (ORR) [ Time Frame: Date of randomization to the date of disease progression (measured every 8 weeks) or death (whichever occurs first). ]The proportion of subjects who have best overall response of complete response (CR) or partial response (PR).
- Health Related Quality of Life (HRQoL) [ Time Frame: Baseline Visit, Day 1 of each subsequent cycle, and at the Off-Treatment Visit ]HRQoL will be assessed using EORTC QLQ-C30, the HCC-specific questionnaire (HC-18), and a generic instrument EQ-5D-3L.
- Plasma PK lenvatinib exposure parameters [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 ]
- Disease control rate [ Time Frame: Best overall response of SD must be at least 7 weeks after randomization ]The proportion of subjects who have best overall response of CR or PR, or stable disease (SD).
- Clinical benefit rate [ Time Frame: Duration of SD ≥ 23 weeks after randomization ]The proportion of subjects who have best overall response of CR or PR or durable SD.
- Exploratory biomarker analysis [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 ]The baseline and/or change from baseline of exploratory soluble, tissue, and/or genetic biomarkers and their correlations with clinical outcomes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761266
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