A Phase I, Multi-center, Non-randomized, Open Label, Drug-drug-interaction Study to Determine the Effect of Multiple Doses of Regorafenib (BAY 73-4506) on the Pharmacokinetics of Probe Substrates of Transport Proteins P-gp (Digoxin; Group A) and BCRP (Rosuvastatin; Group B) in Patients With Advanced Solid Malignant Tumors

Trial Profile

A Phase I, Multi-center, Non-randomized, Open Label, Drug-drug-interaction Study to Determine the Effect of Multiple Doses of Regorafenib (BAY 73-4506) on the Pharmacokinetics of Probe Substrates of Transport Proteins P-gp (Digoxin; Group A) and BCRP (Rosuvastatin; Group B) in Patients With Advanced Solid Malignant Tumors

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 15 May 2017

At a glance

  • Drugs Regorafenib (Primary) ; Digoxin; Rosuvastatin
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 08 May 2017 Planned End Date changed from 1 Mar 2017 to 31 Dec 2017.
    • 07 Nov 2016 Planned End Date changed from 1 Dec 2016 to 1 Mar 2017.
    • 11 Oct 2016 Results assessing the effect of regorafenib on the pharmacokinetics of digoxin and rosuvastatin presented at the 41st European Society for Medical Oncology Congress
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