A phase 1, first-in-human study of AMG 900, an orally administered pan-Aurora kinase inhibitor, in adult patients with advanced solid tumors
Michael Carducci, Montaser Shaheen, Ben Markman, Sara Hurvitz, Daruka Mahadevan, Dusan Kotasek, Oscar B Goodman, Erik Rasmussen, Vincent Chow, Gloria Juan, Gregory R Friberg, Erick Gamelin, Florian D Vogl, Jayesh Desai
INVESTIGATIONAL NEW DRUGS | SPRINGER | Published : 2018
Background Aurora kinase overexpression or amplifications are associated with high proliferation, poor prognosis, and therapeutic resistance in human tumors. AMG 900 is an investigational, oral, selective pan-Aurora kinase inhibitor. Methods This first-in-human trial included dose-escalation and dose-expansion phases ( ClinicalTrials.gov : NCT00858377). Dose escalation evaluated the safety, tolerability, and pharmacokinetics of AMG 900 in advanced solid tumors and determined the maximum tolerated dose (MTD) with/without granulocyte colony-stimulating factor (G-CSF) prophylaxis. Dose expansion evaluated clinical activity in three tumor types: taxane- and platinum-resistant ovarian cancer, tax..View full abstract
Awarded by NATIONAL CANCER INSTITUTE
This study was sponsored by Amgen Inc. Funding for writing of this manuscript was provided by Amgen Inc. Micah Robinson, PhD (Amgen Inc.), as well as Miranda Tradewell, PhD, James Balwit, MS, CMPP, and Rick Davis, MS (Complete Healthcare Communications, LLC; on behalf of Amgen Inc.) assisted with writing the manuscript.