NCT01784978

Efficacy Study of Sunitinib and Everolimus (Rotational vs Sequential Arm) in Pats. With m Clear Cell Renal Cancer

Randomized ph. II Study to Explore Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus vs Sequential Treatment of 1st lIne Sunitinib & 2nd Line EverolimuS Until Progression in Pats Met. Clear Cell Renal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Associació per a la Recerca Oncologica, Spain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.

Detailed description

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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sunitinib	50 mg pd
DRUG	Everolimus	10 mg pd

Timeline

• Start date: 2013-02-12
• Primary completion: 2017-05-08
• Completion: 2017-05-08
• First posted: 2013-02-06
• Last updated: 2017-10-02

Locations

10 sites across 3 countries: France, Greece, Spain