Status:
COMPLETED
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief 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 conti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically or clinically confirmed diagnosis of advanced HCC.
- Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
- Adequate laboratory values/organ function tests.
- Exclusion criteria:
- Simultaneous or metachronous cancers.
- Pericardial, ascites, or pleural effusion requiring drainage.
- Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
- Malabsorption syndrome.
- Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
- Use of drugs known to inhibit cytochrome P3A4.
Exclusion
Key Trial Info
Start Date :
July 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00946153
Start Date
July 24 2009
End Date
August 13 2015
Last Update
February 1 2019
Active Locations (12)
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1
Kashiwa-shi, Chiba, Japan
2
Kurume-shi, Fukuoka, Japan
3
Sapporo, Hokkaido, Japan
4
Kawasaki-shi, Kanagawa, Japan