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
- 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.