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A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC

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Trial Profile

A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2022

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At a glance

  • Drugs Calmangafodipir (Primary)
  • Indications Chemotherapy-induced damage; Peripheral neuropathies
  • Focus Registrational; Therapeutic Use
  • Acronyms POLAR-M
  • Sponsors Egetis Therapeutics
  • Most Recent Events

    • 27 Apr 2022 This trial has been completed in Japan (Date of end of the trial : 31-Aug-2020), according to Japan Pharmaceutical Information Center - Clinical Trials Information record.
    • 03 Jul 2021 Results of post-hoc pooled analysis assessing efficacy (n=351) and safety (n=486) of calmangafodipir to prevent chemotherapy-induced peripheral neuropathy from POLAR-A and POLAR-M trials, presented at the 23rd World Congress on Gastrointestinal Cancer.
    • 15 Dec 2020 Primary endpoint (Proportion of patients (with moderate or severe chronic CIPN) scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-13 (i.e., FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, 9 months after the first dose of IMP (i.e. PledOx or placebo administered on Day 1, Cycle 1 of mFOLFOX6 chemotherapy)) has not been met, according to an Egetis Therapeutics media release.
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