Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-01-01 @ 1:00 PM
Study NCT ID:
NCT01215266
Status:
TERMINATED
Last Update Posted:
2011-09-08
First Post:
2010-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib in Urothelium Cancer of Bladder
Sponsor:
Association of Urologic Oncology (AUO)
Organization:
Study Overview
Official Title:
Prospektiv, Randomisierte, Doppelblinde, Multizentrische Phase-II- Studie Zum Vergleich Der Wirksamkeit Einer Chemotherapie Mit Gemcitabin Plus Cisplatin Und Sorafenib (BAY 43-9006) Versus Gemcitabin Plus Cisplatin Und Plazebo in Der Therapie Des Lokal Fortgeschrittenen Bzw. Metastasierten Urothelkarzinoms AB 31/05 - RUTT 204 - SUSE
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment
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 evaluate the use of Sorafenib additionally to gemcitabine and cisplatin in bladder cancer.
Detailed Description:
A controlled, double-blind, randomized study to evaluate the influence of Sorafenib in bladder cancer patients additionally to chemotherapy with gemcitabine and cisplatin compared to placebo.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2005-006098-29 | EUDRACT_NUMBER | None | View |