Trials / Completed
CompletedNCT01761266
A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 954 (actual)
- Sponsor
- Eisai Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | 12 mg (or 8 mg) once daily (QD) oral dosing. |
| DRUG | Sorafenib | 400 mg twice daily (BID) oral dosing. |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2016-11-13
- Completion
- 2021-03-10
- First posted
- 2013-01-04
- Last updated
- 2022-04-05
- Results posted
- 2018-09-25
Locations
186 sites across 21 countries: United States, Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Philippines, Poland, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01761266. Inclusion in this directory is not an endorsement.