Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

• Status: Terminated
• Trial end date: 2009-11-01

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

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Oxaliplatin; Xaliproden