Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer

Phase 2 Completed 117 enrolled Eli Lilly and Company Roche Pharma AG · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2008-02
Primary completion: 2010-01
Completion: 2011-11

Publications

Wolff RA, Fuchs M, Di Bartolomeo M, Hossain AM, Stoffregen C, Nicol S, Heinemann V. A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. Cancer. 2012 Sep 1;118(17):4132-8. doi: 10.1002/cncr.26692. Epub 2011 Dec 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	enzastaurin	Small molecule	250 mg	Oral
Background	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Study of Enzastaurin With 5-Fluorouracil/Leucovorin (5-FU/LV) Plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colon Cancer

Summary

Timeline

Publications

Drugs

Indications