Ignite Creation Date:
2024-05-06 @ 8:43 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02800330
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2016-05-25
Brief Title:
The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The Effects of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib in Patients With Metastatic Colorectal Cancer mCRC or Gastrointestinal Stromal Tumour GIST
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REGORA
Brief 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 ionizednon-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
Detailed Description:
Patients will start with regorafenib in a loading phase of 21 days and will be admitted for 24 hours to the hospital for pharmacokinetic blood sampling on day 21 49 and 77 1-2 days Patients will be randomized into 2 sequence groups respectively sequences phase A-B-C or phase C-B-A The patient will use regorafenib alone phase A or with esomeprazole for five days phases B and C To completely rule out a pH-dependent DDI between regorafenib and esomeprazole during phase B of the study regorafenib is given concomitantly for five days while during phase C regorafenib is given 3 hours after esomeprazole intake for five days when the intragastric pH is maximally elevated by esomeprazole
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None