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A Phase III, Open-label, Randomized Study of the Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer

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Trial Profile

A Phase III, Open-label, Randomized Study of the Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2021

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At a glance

  • Drugs Cisplatin (Primary) ; Gemcitabine
  • Indications Adenocarcinoma; Adenosquamous carcinoma; Carcinoma; Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Orient Europharma

    • Most Recent Events

    • 27 Dec 2019 According to an NanoCarrier media release, the company has reached the conclusion that NDA will not be submitted with this study as standard regimens in the treatment of pancreatic cancer have been recently changed, and Gemcitabine is not usually used for the 1st line treatment. As for this Phase III study, OEP will conduct the database-lock and detailed statistical analysis.
    • 10 Aug 2017 According to a NanoCarrier media release, Registration of new patients was suspended temporarily due to the effects of the cancellation of the Phase I clinical trials in Japan for combination therapy with radiation for the indication of head and neck cancer, but the company is planning to restart registration of new patients in April 2017.
    • 10 Aug 2017 Status changed from recruiting to suspended, as reported in a NanoCarrier media release.

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