Eisai Clinical Trials

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

E7080-G000-201

Study Overview

E7080
lenvatinib
NCT00784303, 2007-005933-12
Nov 2008 - Mar 2019
Thyroid Cancer

1. Objective Response Rate (ORR) [Time Frame: From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date 11 April 2011, for up to approximately 2 years 5 months]

2. Plasma Pharmacokinetics (PK): Steady State Area Under the Plasma Concentration Curve (AUC) [Time Frame: Cycle 1 Day 1 (predose and at 0.5 and 2 hours postdose), Cycle 1 Day 8 (predose), Cycle 2 Day 1 (predose and at 0.5 and 2 hours postdose), and Cycle 3 Day 1 (predose and at 2 hours postdose) (Cycle length= 28 days)]

  • Males and females 18 Years to 99 Years (Adult, Older Adult)

  • Completed

  • Phase 2

  • Australia, France, Italy, Poland, United Kingdom, United States See more

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.

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