NCT00437268

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-02-19
• Last updated: 2020-07-21
• Results posted: 2020-07-21

Locations

20 sites across 1 country: United States