Terminated/Withdrawn
Sponsor ID
20070879
A Phase 1 dose escalation study of AMG 780 in adult subjects with advanced solid tumors
Study Details
This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Protocol Summary
Primary Outcome Measures
To assess the safety and tolerability of AMG 780 in subjects with advanced solid malignancies (including adverse event rate, incidence of dose-limiting toxicities, and determination of maximum tolerated dose)
Timeframe: 2.5 years
To evaluate the pharmacokinetic (PK) parameters of AMG 780 including, but not limited to Cmax, AUC, and accumulation ratio
Timeframe: 2.5 years
Secondary Outcome Measures
To evaluate tumor response using RECIST criteria (measured by CT/MRI)
Timeframe: 2.5 years
To evaluate changes in tumor volume (measured by volumetric CT/MRI)
Timeframe: 2.5 years
To evaluate changes in tumor vascularity and to estimate the relationship between dose/pharmacokinetics and vascular response (measured by DCE-MRI)
Timeframe: 2.5 years
To evaluate the incidence of anti-AMG 780 antibody formation
Timeframe: 2.5 years
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Los Angeles, CA, United States, 90048
Status
Completed
Location
Research Site
Cleveland, OH, United States, 44106
Status
Completed
Location
Research Site
Durham, NC, United States, 27710
Status
Completed