A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients
Phase of Trial: Phase I/II
Latest Information Update: 22 Mar 2018
At a glance
- Drugs Nintedanib (Primary) ; Sorafenib
- Indications Liver cancer
- Focus Adverse reactions; Therapeutic Use
- Sponsors Boehringer Ingelheim
- 22 Mar 2018 Primary endpoint (Time to Progression (TTP) in Phase II) has not been met, according to published in the British Journal of Cancer.
- 22 Mar 2018 Results (n=125) assessing safety, pharmacokinetics, maximum-tolerated-dose (MTD) per dose-limiting toxicities (DLTs), and efficacy of nintedanib vs. sorafenib in European patients with unresectable advanced hepatocellular carcinoma (aHCC), were published in the British Journal of Cancer.
- 08 Dec 2016 Status changed from active, no longer recruiting to completed.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History