A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment

Eisai Clinical Trials

Protocol # E7080-G000-218

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT03173560, 2016-002778-11

Trial Period: Aug 2017 - Jun 2025

Indication: Renal Cell Carcinoma

Primary Endpoint: 1. Objective Response Rate at Week 24 (ORR24W) [Time Frame: At Week 24]

2. Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks [Time Frame: Up to Week 24]

Population
Males and females 18 Years and older (Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
Australia, Canada, Czechia, Finland, Greece, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Bergerot C, Young Rha S, Pal S, Koralewski P, Stroyakovskiy D, Alekseev B, Parnis F, Castellano D, Lyun Lee J, Sunela K, Ciuleanu T, Heng D, Glen H, Wang J, Bennett L, Pan J, O’Hara K, Puente J. Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma. Oncologist. 2023 Jan 18;28(1):59-71. doi: 10.1093/oncolo/oyac142.

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