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

Phase 2 Terminated 41 enrolled Associació per a la Recerca Oncologica, Spain Novartis · collab Pivotal S.L. · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2013-02-12
Primary completion: 2017-05-08
Completion: 2017-05-08

Outcome

Missed primary endpoint

Stopped (Enrollment): “Lack of recruitment”

paper The primary endpoint was not met. PMID 32654362 ↗

Publications

Rodriguez-Vida A, Bamias A, Esteban E, Saez MI, Lopez-Brea M, Castellano D, Caballero C, Gonzalez-Larriba JL, Calvo E, Macia S, Ravaud A, Bellmunt J. Randomised Phase II study comparing alternating cycles of sunitinib and everolimus vs standard sequential administration in first-line metastatic renal carcinoma (SUNRISES study). BJU Int. 2020 Nov;126(5):559-567. doi: 10.1111/bju.15165. Epub 2020 Aug 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	10 mg	—
Subject	Sunitinib	Small molecule	50 mg	—