NCT03173560

Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \[ORR\] at 24 weeks \[ORR24W\]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (\>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	lenvatinib	lenvatinib capsules.
DRUG	everolimus	everolimus tablets.

Timeline

• Start date: 2017-08-17
• Primary completion: 2020-02-14
• Completion: 2024-06-20
• First posted: 2017-06-02
• Last updated: 2025-04-01
• Results posted: 2021-03-05

Locations

93 sites across 16 countries: United States, Australia, Canada, Czechia, Finland, Greece, Italy, Netherlands, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study