Rechallenge With Panitumumab Driven by RAS Dynamic of Resistance

Summary

This is a hypothesis driven, open label, single-arm, multiple centers, Phase II trial. The trial has been designed to prove or disprove whether a rechallenge with panitumumab can achieve an objective response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients selected on the basis of RAS extended clonal evolution in their plasma.

Timeline

Start

2017-10-11

Primary completion

2019-11-06

Completion

2021-12-31

Outcome

Met primary endpoint

paper The primary endpoint of the trial was met; PMID 35915157 ↗

Publications

• Ciardiello D, Martinelli E, Troiani T, Mauri G, Rossini D, Martini G, Napolitano S, Famiglietti V, Del Tufo S, Masi G, Santini D, Avallone A, Pietrantonio F, Lonardi S, Di Maio M, Zampino MG, Fazio N, Bardelli A, Siena S, Cremolini C, Sartore-Bianchi A, Ciardiello F. Anti-EGFR Rechallenge in Patients With Refractory ctDNA RAS/BRAF wt Metastatic Colorectal Cancer: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Apr 1;7(4):e245635. doi: 10.1001/jamanetworkopen.2024.5635.
• Sartore-Bianchi A, Pietrantonio F, Lonardi S, Mussolin B, Rua F, Crisafulli G, Bartolini A, Fenocchio E, Amatu A, Manca P, Bergamo F, Tosi F, Mauri G, Ambrosini M, Daniel F, Torri V, Vanzulli A, Regge D, Cappello G, Marchio C, Berrino E, Sapino A, Marsoni S, Siena S, Bardelli A. Circulating tumor DNA to guide rechallenge with panitumumab in metastatic colorectal cancer: the phase 2 CHRONOS trial. Nat Med. 2022 Aug;28(8):1612-1618. doi: 10.1038/s41591-022-01886-0. Epub 2022 Aug 1.

Drugs

Indications