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

Study Overview

In this study, you will receive the combination of lenvatinib with everolimus. The main purpose of this study is: To study the effects of this combination of study drugs on your body To determine the highest safe dose of study drugs that can be given in combination To determine what happens to the study drugs in your body (how your body absorbs, distributes, breaks down and excretes these drugs)
To assess biomarkers (markers that may help researchers understand the disease and effectiveness of lenvatinib and everolimus) in blood and tumor tissues To assess any shrinkage in your tumor.

Study Description

The purpose of this study is to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of lenvatinib administered in combination with everolimus, once daily to pediatric subjects with recurrent/refractory solid tumors; and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric subjects with recurrent/refractory solid tumors.

Additional Information

Participants will be paid for their participation.


  • IRB Number: 1707448889 (PHO-COG/EISAI-ADVL1711)
  • Research Study Identifier: TX8312
  • Principal Investigator: James Croop, MD, PhD

Recruitment Status

Open

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