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A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

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Trial Profile

A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

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

Latest Information Update: 02 Oct 2024

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At a glance

  • Drugs Bemarituzumab (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms FORTITUDE-101
  • Sponsors Amgen
  • Most Recent Events

    • 26 Jun 2024 Status changed from recruiting to active, no longer recruiting.
    • 07 Oct 2023 According to Zai Lab media release, the first patient in the mainland China portion of this study has been enrolled in July 2023.
    • 14 Aug 2023 Planned End Date changed from 16 Oct 2026 to 18 Aug 2025.

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