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A Study of IMC-1121B (Ramucirumab) in Colorectal Cancer

NCT00862784 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-17

Study results available
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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.

Conditions

  • Colorectal Carcinoma

Interventions

BIOLOGICAL

IMC-1121B (ramucirumab)

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

DRUG

Oxaliplatin

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

DRUG

Folinic acid

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

DRUG

5-FU

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

DRUG

5-FU

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-04-30
Completion
2011-08-31

Countries

  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00862784 on ClinicalTrials.gov