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A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

Trial Profile

A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Feb 2019

At a glance

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

    • 10 Feb 2019 Status changed from planning to recruiting.
    • 20 Dec 2018 According to a PCI Biotech media release, based on the data from a Phase I extension study (see profile 227287), the company would limit the proposed plan of including up to two fimaChem treatments in this pivotal study. The the company is planning to start this trial in first half 2019. Final analysis is expected at approximately 50 months from initiation.
    • 30 Aug 2018 According to a PCI Biotech media release, preparation for this pivotal study is progressing towards initiation in early 2019.
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