PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI

Summary

This is a multicenter prospective study that includes all patients with metastatic Renal Cell Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers. Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason. A treatment cycle consists of 28 days.

Timeline

Start

2015-09-22

Primary completion

2017-05-05

Completion

2017-09

Publications

• Lolli C, Galla V, Schepisi G, Barone D, Burgio SL, Maugeri A, Vertogen B, Amadori D, De Giorgi U. A Phase II Study of Everolimus Plus Oral Prednisone in Patients with Metastatic Renal Cell Cancer. Oncologist. 2017 Jul;22(7):784-e74. doi: 10.1634/theoncologist.2017-0154. Epub 2017 May 25.

Drugs

Indications