Polar M

• Research type

  Research Study

• Full title

  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 metastatic colorectal cancer

• IRAS ID

  239233

• Contact name

  Andreas Polychronis

• Contact email

  andreas.polychronis@nhs.net

• Sponsor organisation

  PledPharma AB

• Eudract number

  2017-004754-42

• Clinicaltrials.gov Identifier

  ., .

• Duration of Study in the UK

  3 years, 10 months, 0 days

• Research summary

  This is a Phase 3, multicenter, double-blind, placebo-controlled study investigating the efficacy of PledOx in prevention of chronic CIPN induced by oxaliplatin.
  Patients with metastatic colorectal cancer, who are indicated for first-line modified FOLFOX-6 (mFOLFOX6) chemotherapy for at least 3 months, without any pre-planned treatment breaks, will be randomized in a 1:1:1 ratio, stratified by prior oxaliplatin exposure (yes/no), to one of three treatment arms:
  • Arm A: PledOx (2 µmol/kg) + mFOLFOX6 chemotherapy
  • Arm B: PledOx (5 µmol/kg) + mFOLFOX6 chemotherapy
  • Arm C: Placebo + mFOLFOX6 chemotherapy
  A total of 300 patients Worldwide will be randomized in the PP06490 study (100 patients per arm).

  Oxaliplatin, in combination with 5-fluorouracil plus folinate (or capecitabine), has increased survival in stage III colorectal cancer and prolonged life in stage IV patients, but its use is compromised because of severe toxicity. Chemotherapy-induced peripheral neuropathy (CIPN) is the most problematic dose-limiting toxicity of oxaliplatin. No treatments have been clinically proven to prevent CIPN. There is a body of evidence that CIPN is caused by cellular oxidative stress. Clinical and preclinical data suggest that the manganese chelate and superoxide dismutase mimetic calmangafodipir (Ca4Mn(DPDP)5) is an efficacious inhibitor of CIPN and other conditions caused by cellular oxidative stress, without interfering negatively with the tumoricidal activity of chemotherapy.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  18/LO/0645

• Date of REC Opinion

  1 Aug 2018

• REC opinion

  Further Information Favourable Opinion