Polar A

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

• IRAS ID

  245369

• Contact name

  Andreas Polychronis

• Contact email

  andreas.polychronis@nhs.net

• Sponsor organisation

  PledPharma AB

• Eudract number

  2017-004707-43

• Duration of Study in the UK

  2 years, 10 months, 2 days

• Research summary

  This is a Phase 3, multicenter, double-blind, placebo-controlled study with PledOx for prevention of chronic CIPN induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).
  Patients with CRC, who are indicated for adjuvant modified FOLFOX6 (mFOLFOX6) chemotherapy for up to 6 months, will be randomized in a 1:1 ratio to 1 of 2 treatment arms:
  • Arm A: PledOx (5 μmol/kg) + mFOLFOX6 chemotherapy
  • Arm B: Placebo + mFOLFOX6 chemotherapy
  The investigational medicinal product (IMP, i.e. PledOx or placebo) will be administered by an intravenous (i.v.) infusion on the first day of each chemotherapy cycle. IMP will not be administered if mFOLFOX6 is not given to the patient.
  If a patient discontinues mFOLFOX6, the IMP should also be discontinued.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  18/LO/0710

• Date of REC Opinion

  19 Jul 2018

• REC opinion

  Further Information Favourable Opinion