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

Cancer Clinical Trial

Official title:
A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Advanced Solid Tumors

Clinical Trial 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

Clinical Trial Description

that G-CSF must be started at day 5, 1 day after the last day of AMG 900 and be continued until neutrophiles are > 1000 or until day 12, meaning 2 days before the reinduction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00858377
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 1
Start date August 10, 2009
Completion date April 3, 2019
View Details
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