Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-03-06 @ 8:52 AM
Study NCT ID:
NCT01023958
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2009-11-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous BI 6727 (Volasertib) in 2nd Line Treatment of Urothelial Cancer
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
An Open-label, Single-arm, Phase II Trial of Intravenous BI 6727 in Patients With Locally Advanced, Metastatic or Recurrent Urothelial Cancer of the Bladder, Renal Pelvis, or Ureters After Failure of Prior Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-10
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 primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: