Trials / Completed
CompletedNCT00946153
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is administered continually once daily in participants with advanced hepatocellular carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1. |
Timeline
- Start date
- 2009-07-24
- Primary completion
- 2014-06-15
- Completion
- 2015-08-13
- First posted
- 2009-07-24
- Last updated
- 2019-02-01
- Results posted
- 2019-02-01
Locations
12 sites across 2 countries: Japan, South Korea
Source: ClinicalTrials.gov record NCT00946153. Inclusion in this directory is not an endorsement.