CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 158 enrolled
Drug / intervention
Ramucirumab +2 morebiological
Likely dose
Ramucirumab 8 mg/kgfrom 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/NCT01111604
NCT01111604Phase 2Completed

An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy

Eli Lilly and Company·interventional·Posted Apr 27, 2010·Updated Aug 6, 2019

In Brief

A Phase 2 clinical trial evaluating Ramucirumab, Icrucumab, and 1 other intervention for Colon Cancer and Rectal Cancer. Completed, enrolled 158 participants across 17 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2010
Enrollment StartAug 1, 2010
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.2 years ago

Interventions

Ramucirumabbiological

8 mg/kg IV Q2W

Icrucumabbiological

15 mg/kg IV Q2W

mFOLFOX-6drug

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W) FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W