Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-04-14 @ 10:51 AM
Study NCT ID:
NCT01679405
Status:
TERMINATED
Last Update Posted:
2019-09-06
First Post:
2012-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Study Overview
Official Title:
Open-label, Uncontrolled, Multicenter Phase I/Ib Trial to Investigate Safety and Efficacy of BIBW 2992 and Standard Gemcitabine/Cisplatin in Chemo-naïve Patients With Advanced Biliary Tract Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No sufficient clinical or molecular signals for efficacy were observed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An open-label, uncontrolled, multicenter phase I/Ib trial to investigate safety and efficacy of BIBW 2992 added to the standard therapy of Gemcitabine/Cisplatin in chemo-naïve patients with advanced and/or metastatic adenocarcinoma of the biliary tract
Detailed Description:
The primary objective is safety and toxicity, including maximum tolerated dose, of BIBW 2992 when given as add-on therapy to Gem/Cis.
Study Oversight
Has Oversight DMC:
False
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?: