A Randomized Phase II Study to Explore the Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus Versus Sequential Treatment of 1st lIne Sunitinib and 2nd Line EverolimuS Until Progression in Patients Metastatic Clear Cell Renal Cancer
This is an open-label, randomized phase II study to investigate the feasibility of
alternating cycles of treatment with sunitinib and everolimus compared to sequential
treatment of sunitinib followed by everolimus.
The study population consists of adult patients (over 18 years old) with clear cell mRCC
(Metastatic Renal Cell Cancer) who have not received prior therapy for their metastatic
disease.
The purpose of the study is to determine the progression free survival, feasibility and
safety profile of the experimental arm compared to standard of care.
In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks
of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by
12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic
clear cell renal cancer. The comparative arm will be the standard regimen of sunitinib (50
mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously,
11/1) until progression.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) rate 1 year
12 months
No
Joaquim Bellmunt, MD/PhD
Principal Investigator
Associacio Per la Recerca Oncológica (APRO)
Spain: Spanish Agency of Medicines
SUNRISES STUDY (CRAD001LIC34T)
NCT01784978
October 2012
February 2015
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