drugset / Trial / NCT00393822

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

NCT00393822

Phase 2/3 Completed 100 enrolled Amgen
RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.

Timeline

Start
2005-08
Primary completion
2007-12
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Palifermin Protein / enzyme biologic 120 ug/kg Intravenous

Indications