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: 21 Jul 2017

At a glance

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

    • 25 Apr 2017 Planned End Date changed from 1 Dec 2017 to 29 Jan 2018.
    • 25 Apr 2017 Planned primary completion date changed from 1 Jun 2017 to 31 Dec 2017.
    • 13 Feb 2017 Planned primary completion date changed from 1 Dec 2016 to 1 Jun 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top