Study of the Combination of Axitinib Plus Everolimus in Patients With Malignant Advanced Solid Tumors

Summary

The aim of the study is to determine the MTD of the combination of everolimus plus axitinib in solid tumors, especially RCC.

Timeline

Start

2011-03

Primary completion

2013-05

Completion

2015-01

Publications

• Background Su Y, Amiri KI, Horton LW, Yu Y, Ayers GD, Koehler E, Kelley MC, Puzanov I, Richmond A, Sosman JA. A phase I trial of bortezomib with temozolomide in patients with advanced melanoma: toxicities, antitumor effects, and modulation of therapeutic targets. Clin Cancer Res. 2010 Jan 1;16(1):348-57. doi: 10.1158/1078-0432.CCR-09-2087. Epub 2009 Dec 22.
• Background O'Reilly T, Lane HA, Wood JM, Schnell C, Littlewood-Evans A, Brueggen J, McSheehy PM. Everolimus and PTK/ZK show synergistic growth inhibition in the orthotopic BL16/BL6 murine melanoma model. Cancer Chemother Pharmacol. 2011 Jan;67(1):193-200. doi: 10.1007/s00280-010-1307-z. Epub 2010 May 30.
• Background Choueiri TK. Axitinib, a novel anti-angiogenic drug with promising activity in various solid tumors. Curr Opin Investig Drugs. 2008 Jun;9(6):658-71.
• Results Ravaud A, Gomez-Roca C, Picat MQ, Digue L, Chevreau C, Gimbert A, Chauzit E, Sitta R, Cornelis F, Asselineau J, Aziza R, Daste A, Quemener C, Baud J, Bikfalvi A, Pedenon-Perichout D, Doussau A, Molimard M, Delord JP. Phase I study of axitinib and everolimus in metastatic solid tumours and extension to metastatic renal cell carcinoma: Results of EVAX study. Eur J Cancer. 2017 Nov;85:39-48. doi: 10.1016/j.ejca.2017.07.031. Epub 2017 Sep 5.

Drugs

Indications