Study Complete
Sponsor ID
20190131
Study of AMG 650 in Adult Participants with Advanced Solid Tumors
Study Details
To evaluate the safety and tolerability of AMG 650 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: Up to 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 24 months
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to 24 months
Number of Participants with Treatment-related Adverse Events
Timeframe: Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement
Timeframe: Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement
Timeframe: Up to 24 months
Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timeframe: Up to 24 months
Secondary Outcome Measures
Objective Response Rate (ORR)
Timeframe: Up to 24 months
Duration of Response (DOR)
Timeframe: Up to 24 months
Progression-free Survival (PFS)
Timeframe: Up to 24 months
Clinical Benefit Rate (CBR)
Timeframe: Up to 24 months
Time to Response (TTR)
Timeframe: Up to 24 months
Time to Progression (TTP)
Timeframe: Up to 24 months
Overall Survival (OS)
Timeframe: Up to 24 months
Maximum Plasma Concentration (Cmax) of AMG 650
Timeframe: Up to 24 months
Time to Maximum Plasma Concentration (Tmax) of AMG 650
Timeframe: Up to 24 months
Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650
Timeframe: Up to 24 months
Locations
Location
Sarcoma Oncology Research Center LLC
Santa Monica, CA, United States, 90403
Status
Recruiting
Location
Washington University
St. Louis, MO, United States, 63110-1093
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, CA, United States, 90025
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
Location
Sarah Cannon Research Institute
Nashville, TN, United States, 37203
Status
Recruiting
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