Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

Eisai Clinical Trials

Protocol # E7080-G000-201

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT00784303, EU CTR 2007-005933-12

Trial Period: Aug 2009 - Apr 2011

Indication: Thyroid Cancer

Primary Endpoint: Overall tumor response rates of complete response (CR), and partial response (PR) based on modified RECIST assessed by IIR.

Population
Males and females (age 18 years and over)
Study Status
Completed
Study Phase
Phase 2
Countries
Australia, France, Italy, Poland, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Schlumberger M, Jarzab B, Cabanillas ME, Robinson B, Pacini F, Ball DW, et al. A Phase II Trial of the Multitargeted Tyrosine Kinase Inhibitor Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer. CLINICAL CANCER RESEARCH 2016 Jan 01;22(1):44-53. DOI: 10.1158/1078-0432.CCR-15-1127

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.

Redacted documents are available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR