Spots Global Cancer Trial Database for A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors
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
Study ID: NCT00858377
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Tucson, Arizona, United States
Research Site, Los Angeles, California, United States
Research Site, Baltimore, Maryland, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Albuquerque, New Mexico, United States
Research Site, Kurralta Park, South Australia, Australia
Research Site, Bentleigh East, Victoria, Australia
Research Site, Parkville, Victoria, Australia
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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