drugset
drugset / Trial / NCT01133990

FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer

NCT01133990 ↗

Phase 1/2 Terminated 5 enrolled Eisai Inc. Quintiles, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.

Timeline

Start
2010-03-04
Primary completion
2011-02-18
Completion
2011-02-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 5 mg/kg Intravenous
Subject E7820 Small molecule 40 mg Oral
Subject E7820 Small molecule 70 mg Oral
Subject E7820 Small molecule 100 mg Oral
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Leucovorin Small molecule 200 mg/m2 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

Indications

colorectal cancer