Study Complete
Sponsor ID
20180144
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
Study Details
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Protocol Summary
Primary Outcome Measures
Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: 28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 2.5 Years
Number of Participants with Treatment-Related Adverse Events
Timeframe: Up to 2.5 Years
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
Timeframe: Up to 2 Years
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timeframe: Up to 2 Years
Maximum Tolerated Dose (MTD) of AMG 256
Timeframe: 28 days
Recommended Phase 2 Dose (RP2D) of AMG 256
Timeframe: 28 days
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax) of AMG 256
Timeframe: Up to 2.5 Years
Time to Achieve Cmax (Tmax) of AMG 256
Timeframe: Up to 2.5 Years
Area Under the Plasma Concentration-time Curve (AUC) of AMG 256
Timeframe: Up to 2.5 Years
Objective Response (OR)
Timeframe: Up to 2.5 Years
Duration of Response (DOR)
Timeframe: Up to 2.5 Years
Progression-Free Survival (PFS)
Timeframe: Up to 1 Year
Disease Control Rate (DCR)
Timeframe: Up to 2.5 Years
Duration of Stable Disease
Timeframe: Up to 2.5 Years
Overall Survival (OS)
Timeframe: Up to 2 Years
Number of Participants with anti-AMG 256 Antibodies
Timeframe: Up to 2.5 Years
Locations
Location
Indiana University
Indianapolis, IN, United States, 46202
Status
Recruiting
Location
Monash Medical Centre
Clayton, VIC, Australia, 3168
Status
Recruiting
Location
St Vincents Hospital Sydney
Darlinghurst, NSW, Australia, 2010
Status
Recruiting
Location
Hospital Universitari Vall d Hebron
Barcelona, Cataluña, Spain, 08035
Status
Recruiting
Location
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña, Spain, 08036
Status
Recruiting
Location
Chris OBrien Lifehouse
Camperdown, NSW, Australia, 2050
Status
Recruiting
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