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A Multicenter, Randomized, Open-label, 2-arm, Phase II Study With a Safety lead-in Phase Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer

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Trial Profile

A Multicenter, Randomized, Open-label, 2-arm, Phase II Study With a Safety lead-in Phase Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Apr 2025

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At a glance

  • Drugs Cetuximab (Primary) ; Encorafenib (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary)
  • Indications Colorectal cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NAUTICALCRC

Most Recent Events

  • 15 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 15 Jun 2024 Planned End Date changed from 1 Apr 2024 to 11 Jan 2025.
  • 04 Jun 2024 Results (n=97; At data cut-off 19 Dec 2023) assessing the safety and efficacy of encorafenib and cetuximab versus irinotecan/cetuximab or FOLFIRI/cetuximab in patients with BRAF V600E mutant metastatic colorectal cancer, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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