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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 14 Jun 2019

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At a glance

  • Drugs Nintedanib (Primary) ; Sorafenib
  • Indications Liver cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Boehringer Ingelheim

    • Most Recent Events

    • 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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