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
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
- 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.