Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389155
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2006-10-17
Brief Title:
First-Line Treatment of Advanced Bladder Cancer Randomized vs Gemcitabine Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Phase IIIII Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma TCC of the Urothelium Comparing VinflunineGemcitabine to PlaceboGemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy
Status:
COMPLETED
Status Verified Date:
2015-11
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:
The purpose of this study is to test an investigational drug vinflunine BMS-710485 in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone
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