A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors

Summary

This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and dose expansion. The dose escalation part of the study is aimed at evaluating the safety, tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50 subjects may be enrolled in dose escalation. The dose expansion part of the study will consist of 42 subjects in three taxane-resistant tumor types. The dose of AMG 900 will be dependent upon data from the dose escalation part of the study

Timeline

Start

2009-08-10

Primary completion

2014-12-31

Completion

2019-04-03

Publications

• Carducci M, Shaheen M, Markman B, Hurvitz S, Mahadevan D, Kotasek D, Goodman OB Jr, Rasmussen E, Chow V, Juan G, Friberg GR, Gamelin E, Vogl FD, Desai J. A phase 1, first-in-human study of AMG 900, an orally administered pan-Aurora kinase inhibitor, in adult patients with advanced solid tumors. Invest New Drugs. 2018 Dec;36(6):1060-1071. doi: 10.1007/s10637-018-0625-6. Epub 2018 Jul 7.

Drugs

Indications