Randomized double-blind Phase III trial of FOLF(HA)iri vs FOLFIRI for second or third line therapy in irinotecan-naive patients with metastatic colorectal cancer.

Trial Profile

Randomized double-blind Phase III trial of FOLF(HA)iri vs FOLFIRI for second or third line therapy in irinotecan-naive patients with metastatic colorectal cancer.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2016

At a glance

  • Drugs Irinotecan hyaluronic acid complex (Primary) ; Fluorouracil; Folinic acid; Irinotecan; Levofolinic acid
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Alchemia Oncology
  • Most Recent Events

    • 26 Oct 2014 Primary endpoint has not been met (progression-free survival rate), according to an Alchemia media release.
    • 26 Oct 2014 Results published in an Alchemia media release.
    • 09 Oct 2014 Alchemia has announced a database lock of this pivotal trial for the primary efficacy analysis, and results are expected to be reported by the end of October 2014, according to a media release.
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