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A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

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Trial Profile

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2024

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At a glance

  • Drugs Durvalumab (Primary) ; Cisplatin; Gemcitabine
  • Indications Biliary cancer; Cholangiocarcinoma; Gallbladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TOPAZ-1
  • Sponsors AstraZeneca; AstraZeneca AB; AstraZeneca KK

    • Most Recent Events

    • 16 Apr 2024 According to an AstraZeneca media release, data from this trial will be presented on April 18 at the 2024 Cholangiocarcinoma Foundation Conference in Salt Lake City, Utah.
    • 16 Apr 2024 Updated exploratory results from the TOPAZ-1 published in the AstraZeneca Media Release
    • 24 Oct 2023 Results (n=130) assessing the prespecified exploratory analyses assessing the efficacy and safety of durvalumab plus gemcitabine and cisplatin in Chinese participants with advanced biliary tract cancer in an extended cohort of TOPAZ-1 enrolled in China, presented at the 48th European Society for Medical Oncology Congress.
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