A Phase 1 Study of E7080 in Subjects With Solid Tumor

Eisai Clinical Trials

Protocol # E7080-J081-105

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT01268293, JapicCTI-111382, jRCT2080221345

Trial Period: Feb 2011 - Apr 2013

Indication: Solid Tumors

Primary Endpoint:
1. Number of Participants With Dose Limiting Toxicity (DLT) [Time Frame: Up to 4 weeks]

2. Number of Participants With Adverse Events [Time Frame: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).]

Population
Males and females 20 Years and older (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

Nakamichi S, Nokihara H, Yamamoto N, Yamada Y, Honda K, Tamura Y, et al. A phase 1 study of lenvatinib, multiple receptor tyrosine kinase inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol 2015 12;76(6):1153-1161. DOI: 10.1007/s00280-015-2899-0

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