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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761266
Show 177 Study Locations