Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate : P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Single dose of digoxin 0.5 mg (2 tablets 0.25 mg) orally without and with regorafenib
Single dose of rosuvastatin 5mg (1 tablet 5 mg) without and with regorafenib 160 mg q.d. (4 tablets 40 mg)
Once daily orally 160 mg (4 tablets 40 mg)
Unnamed facility
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Herne, North Rhine-Westphalia, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for Digoxin
Time frame: On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
Maximum drug concentration (Cmax) in plasma for Digoxin
Time frame: On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) for rosuvastatin
Time frame: On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
Maximum drug concentration (Cmax) in plasma for rosuvastatin
Time frame: On Pre-Cycle Day -7 and on Cycle 1 Day15 or Cycle 2 Day 15
Tumor Response following RECIST criteria
Time frame: From first dose up to 3 months after end of treatment
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 30 days after last dose
Number of participants with drug related adverse events as a measure of safety and tolerability
Time frame: Up to 30 days after last dose
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Budapest, Hungary