CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,072 enrolled
Drug / intervention
Ramucirumab +4 morebiological
Likely dose
Ramucirumab 8 milligramsfrom 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/NCT01183780
NCT01183780Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

Eli Lilly and Company·interventional·Posted Aug 18, 2010·Updated Sep 25, 2019

In Brief

A Phase 3 clinical trial evaluating Ramucirumab, Placebo, and 3 other interventions for Colorectal Cancer. Completed, enrolled 1,072 participants across 213 sites in 26 countries.

Detailed Summary

The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Netherlands, Portugal, Puerto Rico, Romania, Slovenia, South Korea, Spain, Sweden, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2010
Enrollment StartDec 2, 2010
Primary CompletionJul 17, 2014
Study CompletionJun 20, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.9 years ago

Interventions

Ramucirumabbiological

8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Placebobiological

Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Irinotecandrug

180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Folinic Aciddrug

400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

5-Fluorouracildrug

400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision