CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 181 enrolled
Drug / intervention
Regorafenib (BAY 73-4506) +3 moredrug
Likely dose
Regorafenib (BAY 73-4506) 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/NCT01298570
NCT01298570Phase 2Completed
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Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI Versus Placebo With FOLFIRI as Second-Line Therapy in Patients With Metastatic Colorectal Cancer

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Feb 17, 2011·Updated Jan 6, 2021

In Brief

A Phase 2 clinical trial evaluating Regorafenib (BAY 73-4506), FOLFIRI, and 1 other intervention for Colorectal Cancer Metastatic. Completed, enrolled 181 participants across 24 sites in 2 countries.

Detailed Summary

This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer Metastatic
CountriesIreland, United States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2011
Enrollment StartApr 7, 2011
Primary CompletionNov 15, 2016
Study CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 15.4 years ago

Interventions

Regorafenib (BAY 73-4506)drug

Regorafenib, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle

FOLFIRIdrug

FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.

Placebodrug

Placebo, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle

FOLFIRIdrug

FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.