Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)

Eisai

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Lenvatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946153

E7080-J081-202

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or clinically confirmed diagnosis of advanced HCC.
2. Eastern Cooperative Oncology Group-Performance Status (ECOG-PS): 0-1.
3. Adequate laboratory values/organ function tests.

Exclusion criteria

1. Simultaneous or metachronous cancers.
2. Pericardial, ascites, or pleural effusion requiring drainage.
3. Brain metastasis/meningeal carcinomatosis presenting clinical symptoms or requiring treatment.
4. Malabsorption syndrome.
5. Artery-portal vein shunt or artery-vein shunt preventing proper diagnosis of tumor.
6. Use of drugs known to inhibit cytochrome P3A4.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Lenvatinib

Experimental group

Treatment:

Drug: Lenvatinib