Spots Global Cancer Trial Database for Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
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Trial Identification
Brief Title: Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens
Official Title: A Multi-center, Randomized, Double Blind, Placebo Controlled Phase III Study to Assess the Efficacy of Xaliproden in Patients With Oxaliplatin-induced Peripheral Sensory Neuropathy (PSN) Following Adjuvant Chemotherapy for Colon Cancer
Study ID: NCT00603577
Conditions
Study Description
Brief Summary: Primary objective: To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (PSN) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. Secondary objective: * To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale). * To assess the effect of xaliproden on the rate of at least partial recovery of grade \> 2 PSN at 6 months * To assess the effects of xaliproden on the time to complete recovery from PSN * To evaluate the safety profile of xaliproden
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office, Québec, , Canada
Sanofi-Aventis Administrative Office, Paris, , France
Sanofi-Aventis Administrative Office, Frankfurt, , Germany
Sanofi-Aventis Administrative Office, Kallithea, , Greece
Sanofi-Aventis Administrative Office, Milan, , Italy
Sanofi-Aventis Administrative Office, Barcelona, , Spain
Sanofi-Aventis Administrative Office, Guildford Surrey, , United Kingdom
Contact Details
Name: Jean-Philippe Aussel
Affiliation: Sanofi
Role: PRINCIPAL_INVESTIGATOR
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