Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Emory University School of Medicine/Winship Cancer Institute SC-2
Atlanta, Georgia, United States
Washington University School of Medicine
St Louis, Missouri, United States
Novartis Investigative Site
Sofia, Bulgaria
AUClast of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameters
Time frame: Up to 72 hours post midazolam and caffeine dose
AUCinf of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
Lambda_z of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
Cmax of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
Tmax of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
T1/2 of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
CL/F of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
Vz/F of midazolam and caffeine
midazolam and caffeine pharmacokinetic parameter
Time frame: Up to 72 hours post midazolam and caffeine dose
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Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Dijon, Cote D Or, France
Novartis Investigative Site
Pierre-Bénite, France
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
...and 2 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
Time frame: Baseline, every 6 weeks
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
Time frame: Baseline, every 6 weeks