check_circleStudy Completed

Neoplasms

BAY73-4506 Probe Substrate Study

Trial purpose

- 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

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
41
Trial Dates
August 2011 - July 2018
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Juravinski Cancer CentreHamilton, L8V 5C2, Canada
Completed
British Columbia Cancer Agency-Vancouver CentreVancouver, V5Z 4E6, Canada

Primary Outcome

  • Pharmacokinetics of probe substrates (AUC, Cmax, etc.)
    date_rangeTime Frame:
    Approximately 6 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Tumor Response evaluation measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes
  • Adverse event collection
    date_rangeTime Frame:
    Up to 3 years or longer if indicated
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    Safety Issue:
    Yes

Trial design

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 Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2