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An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer

Trial Profile

An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 26 Feb 2021

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At a glance

  • Drugs Arfolitixorin (Primary) ; Bevacizumab; Fluorouracil; Irinotecan; Oxaliplatin
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Adverse reactions
  • Sponsors Isofol Medical
  • Most Recent Events

    • 17 Jan 2021 Results (n=81) evalauting biomarkers of arfolitixorin/5-FU-based treatment in relation to safety and response in metastatic colorectal cancer, presented at the 2021 Gastrointestinal Cancers Symposium
    • 15 Jan 2021 According to an Isofol Medical media release, gene expression results from the study will be presented at ASCO Gastrointestinal Cancers Symposium (ASCO-GI) 2021.
    • 30 Sep 2020 Results (n=31) from the extension cohort are presented in an Isofol Medical media release.
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