CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Regorafenib +1 moredrug
Likely dose
Regorafenib 160 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02651415
NCT02651415Phase 2Completed
CompareCT.gov

A Phase II Trial of the Effect of Perindopril on HFSR Incidence and Severity in Patients Receiving Regorafenib With Refractory Metastatic Colorectal Carcinoma (mCRC)

British Columbia Cancer Agency·interventional·Posted Jan 11, 2016·Updated Sep 12, 2019

In Brief

A Phase 2 clinical trial evaluating Regorafenib and Perindopril for Metastatic Colorectal Cancer. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to find out what effects the combination of regorafenib and perindopril has on hand-foot skin reaction (HFSR), on high blood pressure (hypertension) and on any other types of side-effects and compare it to the published incidence of the side-effects with regorafenib alone. This research is being done in an attempt to reduce the side-effects associated with regorafenib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesCanada
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 11, 2016
Enrollment StartAug 1, 2016
Primary CompletionMar 1, 2018
Study CompletionNov 7, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.5 years ago

Interventions

Regorafenibdrug

Stivarga® will be used as per the marketed indication ("on label"), Coversyl will be used off-label and as such a Clinical Trial Application will be filed with Health Canada. Regorafenib will be administered 160 mg daily for 21 days of a 28 day cycle. Regorafenib will be administered with low fat breakfast, one hour after perindopril. A low fat breakfast as defined by the Stivarga ® (regorafenib) Product Monograph is one that is \<30% fat, \~300-550 calories.

Perindoprildrug

COVERSYL® (perindopril erbumine) 4 mg will be administered daily for 21 days of a 28 day cycle. Perindopril will be administered orally, first thing in the morning on an empty stomach.