A pivotal, randomised, two-arm study of fimaporfin in combination with gemcitabine for treatment of inoperable cholangiocarcinoma (bile duct cancer)

Trial Profile

A pivotal, randomised, two-arm study of fimaporfin in combination with gemcitabine for treatment of inoperable cholangiocarcinoma (bile duct cancer)

Planning
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2017

At a glance

  • Drugs Fimaporfin (Primary) ; Gemcitabine (Primary)
  • Indications Cholangiocarcinoma
  • Focus Registrational; Therapeutic Use
  • Sponsors PCI Biotech
  • Most Recent Events

    • 27 Dec 2017 New trial record
    • 20 Dec 2017 According to a PCI Biotech media release, the company is planning to initiate this study during the first half of 2018.
    • 20 Dec 2017 According to a PCI Biotech media release, the company is working on design of this trial along with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) to support future marketing authorisation applications in EU and the USA. Interim results of this trial will support accelerated/conditional approval. Further information on the study will be announced following completion of discussions with regulators and clinical advisors.
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