NCT03245151

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent/refractory solid tumors including Ewing sarcoma, rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure.

Conditions

• Recurrent and Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	Lenvatinib	oral hard capsules containing 1 mg, 4 mg, or 10 mg lenvatinib, or an extemporaneous suspension
DRUG	Everolimus	2 mg, 3 mg, or 5 mg tablets for oral suspension

Timeline

• Start date: 2017-11-16
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2017-08-10
• Last updated: 2023-08-30
• Results posted: 2023-08-30

Locations

50 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study