An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

Eisai Clinical Trials

Protocol # E7080-J081-103

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT00280397, JapicCTI-070435, jRCT2080220426

Trial Period: Jan 2006 - Nov 2008

Indication: Solid Tumors

Primary Endpoint:
1. Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day [Time Frame: up to 4 weeks]

2. DLT of E7080 Repeatedly Administered Twice a Day [Time Frame: up to 4 weeks]

Population
Males and females 20 Years to 75 Years (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 1
Countries
Japan

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Koyama N, Saito K, Nishioka Y, Yusa W, Yamamoto N, Yamada Y, et al. Pharmacodynamic change in plasma angiogenic proteins: A dose-escalation phase 1 study of the multi-kinase inhibitor lenvatinib. BMC Cancer 2014 Jul 21;14(1). DOI: 10.1186/1471-2407-14-530

Yamada K, Yamamoto N, Yamada Y, Nokihara H, Fujiwara Y, Hirata T, Koizumi F, Nishio K, Koyama N, Tamura T. Phase I dose-escalation study and biomarker analysis of E7080 in patients with advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2528-37. doi: 10.1158/1078-0432.CCR-10-2638. Epub 2011 Mar 3.

Data Sharing

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CSDR Sharing is 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