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Spots Global Cancer Trial Database for BAY73-4506 Probe Substrate Study

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Trial Identification

Brief Title: BAY73-4506 Probe Substrate Study

Official Title: 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

Study ID: NCT01287598

Conditions

Neoplasms

Study Description

Brief Summary: * To evaluate the effect of BAY73-4506 on the pharmacokinetics of probe substrates of CYP 2C9 (warfarin), 2C19 (omeprazole) and 3A4 (midazolam) administered in a cocktail approach and on the pharmacokinetics of a probe substrate of CYP 2C8 (rosiglitazone) * To evaluate safety, anti-tumor activity, pharmacokinetics, and pharmacodynamics of BAY73-4506 in patients with advanced solid tumors

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cross Cancer Institute, Edmonton, Alberta, Canada

British Columbia Cancer Agency-Vancouver Centre, Vancouver, British Columbia, Canada

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada

Contact Details

Name: Bayer Study Director

Affiliation: Bayer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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