MedTrace Logo

A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Participants With Colorectal Cancer

NCT00437268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-07-21

Study results available
· View outcomes & findings →

Summary

To see how well enzastaurin in combination with irinotecan and cetuximab works versus irinotecan and cetuximab in participants who have progressed within 3 months.

Conditions

Interventions

DRUG

enzastaurin

1125 milligrams (mg) loading dose, then 500 mg orally, daily, of each 21-day cycle until progressive disease

DRUG

irinotecan

300 milligrams per square meter (mg/m\^2) intravenously on Day 1 of each 21-day cycle until progressive disease

DRUG

cetuximab

400 mg/m\^2, intravenously on Day 1, 250 mg/m\^2 on Day 8, Day 15 Cycle 1 then 250 mg/m\^2, on Day 1, 8 and 15 of each cycle, intravenously 21-day cycles until progressive disease

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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00437268 on ClinicalTrials.gov