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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 the adjuvant treatment of patients with Stage III or high-risk Stage II colorectal cancer

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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 the adjuvant treatment of patients with Stage III or high-risk Stage II colorectal cancer

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-A
  • 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 (To compare PledOx versus Placebo with respect to the proportion of patients with moderate or severe chronic chemotherapy induced peripheral neuropathy) has not been met, according to an Egetis Therapeutics media release.

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