Last updated on November 2019

Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer


Brief description of study

This study is to evaluate PledOx for prevention of chronic chemotherapy induced peripheral neuropathy induced by oxaliplatin in patients with Stage III or high-risk Stage II colorectal cancer (CRC).

Detailed Study Description

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 mol/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 oxaliplatin, treatment with 5-FU/folinate and IMP may be continued.

Clinical Study Identifier: NCT04034355

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