Terminated/Withdrawn
Sponsor ID
20180273
Study of AMG 160 in Subjects with Non-Small Cell Lung Cancer
Study Details
This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).
Protocol Summary
Primary Outcome Measures
Number of Participants who Experience One or More Dose-limiting Toxicities (DLTs)
Timeframe: 28 days
Number of Participants who Experience One or More Treatment-emergent Adverse Event (TEAE)
Timeframe: Up to 3 years
Number of Participants who Experience One or More Treatment-related Adverse Events
Timeframe: Up to 3 years
Number of Participants who Experience Clinically Significant Changes in Vital Signs
Timeframe: Up to 3 years
Number of Participants who Experience Clinically Significant Changes in Clinical Laboratory Tests
Timeframe: Up to 3 years
Secondary Outcome Measures
Objective Response (OR) per Modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: Up to 3 years
Overall Survival
Timeframe: Up to 3 years
Progression-free Survival (PFS)
Timeframe: Up to 3 years
Time to Response
Timeframe: Up to 3 years
Time to Progression
Timeframe: Up to 3 years
Duration of Response
Timeframe: Up to 3 years
Time to Subsequent Therapy
Timeframe: Up to 3 years
Locations
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
Location
Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Completed
Location
Universitaetsklinikum Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Status
Completed