Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305188
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2006-03-20
Brief Title:
Evaluation of the Efficacy of Xaliproden SR57746A in Preventing the Neurotoxicity of Oxaliplatin 5FULV Chemotherapy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
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-FULV
Status:
COMPLETED
Status Verified Date:
2016-04
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:
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 G234 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
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 G234 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
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 |
|---|---|---|---|
| EUDRACT 2005-002570-30 | None | None | None |