CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
enzastaurin +2 moredrug
Likely dose
enzastaurin 1125 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/NCT00437268
NCT00437268Phase 2Completed
CompareCT.gov

A Randomized Phase 2 Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Patients With Recurrent Colorectal Cancer

Eli Lilly and Company·interventional·Posted Feb 19, 2007·Updated Jul 21, 2020

In Brief

A Phase 2 clinical trial evaluating enzastaurin, irinotecan, and 1 other intervention for Colorectal Cancer and 2 related conditions. Completed, enrolled 26 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer, Colorectal Carcinoma, Colorectal Tumor
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 19, 2007
Enrollment StartMar 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.4 years ago

Interventions

enzastaurindrug

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

irinotecandrug

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

cetuximabdrug

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