CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
IMC-1121B (ramucirumab) +4 morebiological
Likely dose
IMC-1121B (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/NCT00862784
NCT00862784Phase 2Completed
CompareCT.gov

An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B in Combination With 5-FU/FA and Oxaliplatin (Modified FOLFOX-6) as First-line Therapy in Patients With Metastatic Colorectal Cancer

Eli Lilly and Company·interventional·Posted Mar 17, 2009·Updated Jun 17, 2014

In Brief

A Phase 2 clinical trial evaluating IMC-1121B (ramucirumab), Oxaliplatin, and 2 other interventions for Colorectal Carcinoma. Completed, enrolled 48 participants across 7 sites in 2 countries.

Detailed Summary

The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Carcinoma
CountriesCanada, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2009
Enrollment StartApr 1, 2009
Primary CompletionApr 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.3 years ago

Interventions

IMC-1121B (ramucirumab)biological

8 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) infusions every 2 weeks

Oxaliplatindrug

85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1

Folinic aciddrug

400 mg/m² intravenous infusion over 2 hours on Day 1

5-FUdrug

400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion

5-FUdrug

2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU on Days 1 and 2