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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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 May 2019

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At a glance

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

    • 08 May 2019 According to a Isofol Medical Media Release, the study first extension arm with an additional 20 patients was designed to further evaluate the safety and efficacy of the selected dose regimen (arfolitixorin in combination treatment with 5-FU and oxaliplatin or irinotecan). A second extension arm of an additional 20 patients are currently undergoing treatment and preliminary 8-week early tumor shrinkage data is expected mid-2019 and follow-up data for best response of ORR expected (2019 end).
    • 08 May 2019 According to a Isofol Medical Media Release, the company today announced positive results from 19 patients treated for 8-32 weeks.
    • 17 Jan 2019 Results from open-label extension part were presented in an Isofol Medical media release.
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