Study Complete
Sponsor ID
20190147
AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).
Study Details
To evaluate safety, tolerability, PK, and preliminary efficacy of AMG 510 PO QD in subjects of Chinese descent with KRAS p.G12C-mutant advanced/metastatic solid tumors.
Protocol Summary
Primary Outcome Measures
Subject incidence of Dose-limiting toxicities (DLT)
Timeframe: 6 to 12 months
Number of participants with treatment-emergent adverse events
Timeframe: 6 to 12 months
Number of participants with treatment-related adverse events
Timeframe: 6 to 12 months
Number of participants with changes in vital signs
Timeframe: 6 to 12 months
Number of participants with changes in electrocardiograms (ECGs)
Timeframe: 6 to 12 months
Number of participants with changes in clinical laboratory tests
Timeframe: 6 to 12 months
maximum observed plasma concentration (Cmax) of AMG 510.
Timeframe: 6 to 12 months
time to achieve Cmax (tmax) of AMG 510
Timeframe: 6 to 12 months
area under the plasma concentration time curve (AUC) of AMG 510
Timeframe: 6 to 12 months
Secondary Outcome Measures
Objective response measured by computed tomography (CT) or magnetic resonance imaging (MRI)
Timeframe: 6 to 12 months
Duration of response measured by computed tomography (CT) or magnetic resonance imaging (MRI)
Timeframe: 6 to 12 months
Progression-free survival (PFS) measured by computed tomography (CT) or magnetic resonance imaging (MRI)
Timeframe: 6 to 12 months
Disease control time measured by computed tomography (CT) or magnetic resonance imaging (MRI)
Timeframe: 6 to 12 months
Time to response (TTR) measured by computed tomography (CT) or magnetic resonance imaging (MRI)
Timeframe: 6 to 12 months
Duration of stable disease measured by computed tomography (CT) or magnetic resonance imaging (MRI)
Timeframe: 6 to 12 months
Locations
Location
Veterans General Hospital - Taichung
Taichung, Taichung, Taiwan, 40705
Status
Recruiting
Location
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 10002
Status
Recruiting
Location
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Status
Recruiting
Location
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Status
Recruiting