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  • E7080-G000-218

    Acronym: 

    E7080-G000-218

    ACTRN/NCT /ethics: 

    NCT03173560

    Scientific title: 

    Trial to Assess Safety and Efficacy of Lenvatinib in Combination With Everolimus in Participants With Renal Cell Carcinoma

    Summary of trial and patient characteristics

    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase II Tumour Stream Kidney
    Age Range 18 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2017-08-21
    Molecular Target Anticipated End Date
    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Kidney
    Cancer Stage All stages
    Anticipated Start Date 2017-08-21
    Anticipated End Date

    Trial 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 = Grade 3 adverse events (AEs) in the first 24 weeks after randomization).

    Lay Summary

    Trial to Assess Safety and Efficacy of Lenvatinib in Combination With Everolimus in Participants With Renal Cell Carcinoma

    Sponsor / Cooperative group

    Eisai

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting