Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Indiana University Simon Cancer Center SC
Indianapolis, Indiana, United States
Novartis Investigative Site
Salzburg, Austria
Incidence of Dose limiting toxiticites (DLTs)
Time frame: During the first 28 days on INC280 treatment; cycle = 21 days
Frequency of DLTs
Time frame: During the first 28 days on INC280 treatment
Category of DLTs
Time frame: During the first 28 days on INC280 treatment
AUClast for INC280
Time frame: Treatment Cycle 1 Day 1 (C1D1), C1D7, C1D15, C2D1, C3D1
AUCtau for INC280
Time frame: C1D1, C1D7, C1D15, C2D1, C3D1
Cmax for INC280
Time frame: C1D1, C1D7, C1D15, C2D1, C3D1
Tmax
Time frame: C1D1, C1D7, C1D15, C2D1, C3D1
Adverse events based on CTCAE grading and other safety variables (e.g. EGC readings, physical examination, vital signs and laboratory results).
Time frame: Screening, until 30 days post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Herlev, Denmark
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Nijmegen, Netherlands
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
...and 7 more locations