Ignite Creation Date:
2024-05-05 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00625664
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2008-02-19
Brief Title:
Larotaxel Cisplatin Versus Gemcitabine Cisplatin in First Line Treatment of Locally AdvancedMetastatic Urothelial Tract or Bladder Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Study of LAROTAXEL Cisplatin LC vs Gemcitabine Cisplatin GC in the First Line Treatment of Locally AdvancedMetastatic Urothelial Tract or Bladder Cancer
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:
CILAB
Brief Summary:
This is a randomized open-label multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advancedmetastatic urothelial tract or bladder cancer The primary objective is to compare overall survival Secondary objectives include comparisons of progression free survival objective response rate time to definitive deterioration of performance status duration of response time to definitive weight loss and assessments of overall safety and pharmacokinetics Patients are treated until disease progression death or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first
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 2007-001943-23 | None | None | None |