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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Jul 2018

At a glance

  • Drugs Calmangafodipir (Primary)
  • Indications Chemotherapy-induced damage
  • Focus Registrational; Therapeutic Use
  • Acronyms POLAR-A
  • Sponsors PledPharma
  • Most Recent Events

    • 14 Jun 2018 According to the Solasia Pharma media release, Phase III clinical trials in Asian region including Japan, will start in the second half of 2018 as an extension of the Phase III clinical trial that will be conducted under the initiative of PledPhtrial. This trial will enroll 280 patients of which 80 patients in Asian region.
    • 13 Jun 2018 According to a PledPharma media release, the company intends to submit clinical study applications for an expansion of another 200 patients to be included in the POLAR studies.
    • 13 Jun 2018 Planned End Date changed to 11 Mar 2021.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top