At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin With 5-FU/LV Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Enzastaurin, Placebo, and 3 other interventions for Colorectal Cancer. Completed, enrolled 117 participants across 26 sites in 6 countries.
Detailed Summary
This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.
Study Details
Timeline
Interventions
1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease
oral, daily (up to 1 yr or until progressive disease)
400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
400 mg/m\^2 bolus then 2400 mg/m\^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)
5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)