A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Eisai Clinical Trials

Protocol # E7080-A001-216

Study Overview

Study Compound: E7080

Drug Name: lenvatinib

Registry #: NCT03245151, 2022-003736-77

Trial Period: Nov 2017 - Sep 2022

Indication: Recurrent and Refractory Solid Tumors

Primary Endpoint:
1. Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus [Time Frame: Cycle 1 (Each cycle was of 28 days)]

2. Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus [Time Frame: Cycle 1 (Each cycle was of 28 days)]

Population
Males and females 2 Years to 21 Years (Child, Adult)
Study Status
Completed
Study Phase
Phase 1 / 2
Countries
Canada, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Data Sharing

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CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

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Protocol
SAP
Sample CRF
Full CSR