Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272051
Status:
COMPLETED
Last Update Posted:
2006-09-13
First Post:
2006-01-03
Brief Title:
XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin 5-FULV Chemotherapy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FULV Combination in First-Line Treatment of Patients With Metastatic Colorectal CarcinomaMCRC
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FULV chemotherapy in patients with metastatic colorectal carcinomaPrimary objectives Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group Compare the response rate between treatment group and placebo groupSecondary objectives neurotoxicity parameters overall incidence time and dose to onset time to recovery change in the sensory action potentials antitumoral efficacy progression-free survival overall survival safety profile
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SR57746A | None | None | None |