Phase I/II Study of E7080 in Patients With Advanced Hepatocellular Carcinoma (HCC)

Eisai Clinical Trials

Protocol # E7080-J081-202

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT00946153, JapicCTI-101007, jRCT2080220974

Trial Period: Jul 2009 - Aug 2015

Indication: Hepatocellular Carcinoma (HCC)

Primary Endpoint:
1. Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib [Time Frame: Up to 28 days (Cycle1)]

2. Phase 2: Time to Progression (TTP) by Independent Review Assessment [Time Frame: From day of registration to the day when PD was first confirmed (approximately up to 6.1 years)]

Population
Males and females 20 Years to 80 Years (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 1 / 2
Countries
Japan, Korea, Republic of See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Ikeda K, Kudo M, Kawazoe S, Osaki Y, Ikeda M, Okusaka T, Tamai T, Suzuki T, Hisai T, Hayato S, Okita K, Kumada H. Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma. J Gastroenterol. 2017 Apr;52(4):512-519. doi: 10.1007/s00535-016-1263-4. Epub 2016 Oct 4.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR