NCT01679405

BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Disease

Interventions

Type	Name	Description
DRUG	BIBW 2992	once daily per os

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-09-06
• Last updated: 2019-09-06
• Results posted: 2019-01-22

Locations

1 site across 1 country: Germany