Terminated/Withdrawn
Sponsor ID
20140131
Safety study of AMG 228 to treat solid tumors
Study Details
The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
Protocol Summary
Primary Outcome Measures
Subject incidence of dose limiting toxicities (DLT)
Timeframe: 9 months
Subject incidence of treatment-emergent adverse events
Timeframe: 9 months
Subject incidence of treatment-related adverse events
Timeframe: 9 months
Subject incidence of clinically significant changes in vital signs and physical assessments
Timeframe: 9 months
Subject incidence of clinically significant changes in ECGs
Timeframe: 9 months
Subject incidence of clinically significant changes in clinical laboratory tests
Timeframe: 9 months
AMG 228 maximum observed concentration (Cmax)
Timeframe: 9 months
AMG 228 minimum observed concentration (Cmin)
Timeframe: 9 months
AMG 228 area under the concentration-time curve (AUC)
Timeframe: 9 months
AMG 228 half-life (t1/2)
Timeframe: 9 months
Secondary Outcome Measures
Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timeframe: 9 months
Incidence of anti-AMG 228 antibody formation
Timeframe: 9 months
Activation status and changes in numbers of T regulator cells (Treg)
Timeframe: 9 months
Subject objective response per immune-related Response Criteria (irRC)
Timeframe: 9 months
Activation status of cytotoxic T lymphocytes (CTL)
Timeframe: 9 months
Changes in numbers of cytotoxic T lymphocytes (CTL)
Timeframe: 9 months
Locations
Location
Research Site
New York, NY, United States, 10032
Status
Recruiting
Location
Research Site
Parkville, VIC, Australia, 3050
Status
Recruiting
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
New Haven, CT, United States, 06520
Status
Recruiting
Location
Research Site
Villejuif, France, 94805
Status
Recruiting
Location
Research Site
La Jolla, CA, United States, 92093
Status
Recruiting
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