A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

Eisai Clinical Trials

Protocol # E7080-G000-230

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT04154189, 2019-003696-19

Trial Period: Mar 2020 - Aug 2023

Indication: Osteosarcoma

Primary Endpoint: 1. Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment [Time Frame: From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first (up to 20.5 months)]

Population
Males and females 2 Years to 25 Years (Child, Adult)
Study Status
Completed
Study Phase
Phase 2
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Hong Kong, Ireland, Israel, Italy, Korea, Republic of, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.
Gaspar N, Campbell-Hewson Q, Huang J, Okpara CE, Bautista F. OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma. Future Oncol. 2021 Nov;17(32):4249-4261. doi: 10.2217/fon-2021-0743. Epub 2021 Aug 12.

Data Sharing

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CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR