Colorectal Neoplasms Clinical Trial
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
Primary objective:
To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the
rate of complete resolution of 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 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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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