A Phase I, Non-randomized Open-label Study to Evaluate the Effect of BAY73-4506 (Regorafenib) on Probe Substrates of CYP 2C9 (Warfarin), 2C19 (Omeprazole) and 3A4 (Midazolam) in a Cocktail Approach (Group A) and on a Probe Substrate of CYP 2C8 (Rosiglitazone, Group B) in Patients With Advanced Solid Tumors.

Trial Profile

A Phase I, Non-randomized Open-label Study to Evaluate the Effect of BAY73-4506 (Regorafenib) on Probe Substrates of CYP 2C9 (Warfarin), 2C19 (Omeprazole) and 3A4 (Midazolam) in a Cocktail Approach (Group A) and on a Probe Substrate of CYP 2C8 (Rosiglitazone, Group B) in Patients With Advanced Solid Tumors.

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Jul 2018

At a glance

  • Drugs Regorafenib (Primary) ; Midazolam; Omeprazole; Rosiglitazone; Warfarin
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 05 Jul 2018 Planned primary completion date changed from 31 Dec 2018 to 14 Dec 2018.
    • 04 Feb 2018 Planned End Date changed from 29 Jan 2018 to 29 Jan 2019.
    • 04 Feb 2018 Planned primary completion date changed from 31 Dec 2017 to 31 Dec 2018.
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