Eisai Clinical Trials

Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

E7080-G000-207

Study Overview

E7080
lenvatinib
NCT02432274, 2013-005534-38
Dec 2014 - Jul 2022
Refractory or relapsed solid malignancies
1. Cohort 1: Recommended Dose (RD) of Lenvatinib [Time Frame: Cycle 1 (28 days)]

2. Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR) [Time Frame: From date of first dose of study drug until first documentation of PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)]

  • Males and females 2 Years to 25 Years (Child, Adult)

  • Completed

  • Phase 1 / 2

  • France, Germany, Italy, Spain, United Kingdom, United States See more

Results

CSR Synopsis

No download available

Lay Summary

Download PDF
Publication reference citation

Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆. ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.

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