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

• Status: Completed
• Trial end date: 2015-08-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Lenvatinib

Criteria

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.