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The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib

NCT02800330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-08-02

No results posted yet for this study

Summary

Regorafenib is a novel oral multi-kinase inhibitor which targets angiogenic, stromal and oncogenic receptor tyrosine kinases. It is currently registered for GIST and mCRC. When regorafenib is co-administered with an acid suppressive agent, the intra-gastric pH increases, and as a result the equilibrium of ionized/non-ionized regorafenib may shift to the less soluble non-ionized form which reduces regorafenib bioavailability and exposure. Since proton pump inhibitors (PPIs) are often used during regorafenib therapy, this drug-drug interaction (DDI) confronts pharmacists and oncologists with challenges in clinical practice. In this study the investigators will therefore evaluate the impact of PPI-induced intra-gastric pH elevation on regorafenib pharmacokinetics in patients with GIST and mCRC.

Conditions

Interventions

DRUG

Esomeprazole 40mg concomitantly

During phase B the patients will use esomeprazole 40mg concomitantly with regorafenib for 5 days.

DRUG

Esomeprazole 40mg before

During phase C the patients will use esomeprazole 40mg 3 hours before regorafenib for 5 days.

DRUG

Regorafenib 160mg or 120mg

Patients will use regorafenib 160mg or 120mg during all phases (A, B, C)

Sponsors & Collaborators

Principal Investigators

  • R.H.J. Mathijssen, MD, PhD · EMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
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 NCT02800330 on ClinicalTrials.gov