Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top