EVESOR: a Phase 1 Trial of Everolimus and Sorafenib

Summary

EVESOR multiparameter phase I trial aims at determining the safety of different doses and dosing schedules of everolimus in combination with sorafenib as well as the recommended doses \& dosing schedules for phase 2 trials in adult patients with advanced solid tumors.

Timeline

Start

2013-04

Primary completion

2013-05

Completion

2015-10

Publications

• Puszkiel A, You B, Payen L, Lopez J, Guitton J, Rousset P, Fontaine J, Peron J, Maillet D, Tartas S, Bonnin N, Trillet-Lenoir V, Colomban O, Augu-Denechere D, Freyer G, Tod M. A PK-PD model linking biomarker dynamics to progression-free survival in patients treated with everolimus and sorafenib combination therapy, EVESOR phase I trial. Cancer Chemother Pharmacol. 2023 May;91(5):413-425. doi: 10.1007/s00280-023-04520-z. Epub 2023 Apr 3.
• Varnier R, Puszkiel A, Tod M, Calattini S, Payen L, Lopez J, Guitton J, Schwiertz V, Fontaine J, Peron J, Maillet D, Tartas S, Bonnin N, Colomban O, Augu-Denechere D, Freyer G, You B. Clinical results of the EVESOR trial, a multiparameter phase I trial of everolimus and sorafenib combination in solid tumors. Cancer Chemother Pharmacol. 2023 May;91(5):361-373. doi: 10.1007/s00280-023-04508-9. Epub 2023 Feb 25.
• El-Madani M, Colomban O, Tod M, Maillet D, Peron J, Rodriguez-Lafrasse C, Badary OA, Valette PJ, Lefort T, Cassier P, El-Shenawy SM, El-Demerdash E, Hommel-Fontaine J, Guitton J, Gagnieu MC, Ibrahim BM, Barrois C, Freyer G, You B. EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib. Future Oncol. 2017 Apr;13(8):679-693. doi: 10.2217/fon-2016-0357. Epub 2017 Jan 12.

Drugs

Indications