NCT00305188

Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 879 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).

Conditions

• Metastases
• Colorectal Neoplasms
• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Xaliproden (SR57746A)	oral administration
DRUG	Placebo	oral administration
DRUG	Oxaliplatin	IV administration
DRUG	5-Fluorouracil	IV administration
DRUG	Leucovorin	IV administration

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-03-21
• Last updated: 2016-05-04

Locations

13 sites across 13 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Germany, Hungary, Italy, Poland, Portugal, Spain, United Kingdom