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A phase I/II trial of arfolitixorin as a first-line treatment in combination with 5-FU-based chemotherapy in patients with metastatic colorectal cancer

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Trial Profile

A phase I/II trial of arfolitixorin as a first-line treatment in combination with 5-FU-based chemotherapy in patients with metastatic colorectal cancer

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 May 2025

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At a glance

  • Drugs Arfolitixorin (Primary) ; Fluorouracil (Primary)
  • Indications Colorectal cancer
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 28 Apr 2025 According to an Isofol Medical BA media release, first patient has been included in this trial.
  • 28 Apr 2025 According to an Isofol Medical media release, status changed from planning to recruiting. The study will be conducted in two stages, where phase Ib part will assess the benefit/risk profile of escalating dose. The second part of the trial compares, in line with FDA and EMA guidance, the highest dose from phase Ib with one of the lower doses, with efficacy parameters as primary endpoints.
  • 21 Mar 2025 According to an Isofol Medical BA media release, company announces that the regulatory authority in Germany, BfArM, has given their final approval for the initiation of this clinical trial. The study will initially be conducted in Germany, where patient recruitment will commence shortly. and Dr. Sebastian Stintzing is the investigator of this study.

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