NCT00858377

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Advanced Malignancy
• Advanced Solid Tumors
• Cancer
• Solid Tumors
• Tumors

Interventions

Type	Name	Description
DRUG	Arm 1- Dose Escalation	AMG 900 is a small molecule inhibitor of aurora kinases A, B and C. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
DRUG	Arm 1- Dose Expansion	AMG 900 is a small molecule inhibitor of aurora kinases A, B and C. AMG 900 will be administered daily for 4 days every 2 weeks (i.e., 4 consecutive days of dosing followed by 10 consecutive days off treatment).

Timeline

• Start date: 2009-08-10
• Primary completion: 2014-12-31
• Completion: 2019-04-03
• First posted: 2009-03-09
• Last updated: 2019-05-06

Locations

8 sites across 2 countries: United States, Australia