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BAY73-4506 Probe Substrate Study

NCT01287598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-07-10

No results posted yet for this study

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

Conditions

  • Neoplasms

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

BAY73-4506 administered once a daily (od) in a 21-day on / 7-day off schedule

DRUG

Warfarin

CYP 2C9 (warfarin) at Cycle 1

DRUG

Omeprazole

CYP 2C19 (omeprazole) at Cycle 1

DRUG

Midazolam

CYP 3A4 (midazolam) at Cycle 1

DRUG

Rosiglitazone

CYP2C8 (rosiglitazone) at Cycle 1

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-02
Primary Completion
2018-07-03
Completion
2018-07-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01287598 on ClinicalTrials.gov