the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Emory University School of Medicine/Winship Cancer Institute Phase 1 Working Group
Atlanta, Georgia, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Novartis Investigative Site
AUClast of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
AUCinf of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
Lambda_z of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
Cmax of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
Tmax of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
T1/2 of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
CL/F of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
Vz/F of digoxin and rosuvastatin
digoxin and rosuvastatin pharmacokinetics parameters
Time frame: Up to 240 hours post digoxin and rosuvastatin dose
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Vienna, Austria
Novartis Investigative Site
Edegem, Antwerpen, Belgium
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Ioannina, GR, Greece
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Candiolo, TO, Italy
Novartis Investigative Site
Bologna, Italy
...and 5 more locations
Adverse events based on the CTCAE v4.03 grade (severity) and other safety data (e.g.,ECG, vital signs, laboratory results)
To assess safety and tolerability of INC280 in patients with cMET-dysregulated advanced solid tumors
Time frame: From consent to 30 days post last dose
Overall response rate of patients treated with INC280
Overall response rate is defined as Complete Response and Partial Response calculated per RECIST 1.1, per investigator assessment from Day 1 until date of progression or death whichever comes first
Time frame: Up to 12 months
Disease control rate of patients treated with INC280
Disease control rate is defined as calculated as the proportion of patients with best overall response of Complete Response, Partial Response, or Stable Disease calculated per RECIST 1.1, per investigator assessment from Day 1 until date of progression or death whichever comes first
Time frame: Up to 12 months
Concentration of INC280 during DDI phase
INC280 concentrations collected on Day 22 during DDI phase and Cycle 2 Day 1 during post DDI phase along with a listing of individual values.
Time frame: Day 22, Cycle 2 Day 1