A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Q2W during treatment, Q4W to Q12W during post-treatment follow-up
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC5505
NCT00305188
December 2005
October 2009
Name | Location |
---|---|
Sanofi-Aventis Administrative Office | Bridgewater, New Jersey 08807 |