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Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer

NCT04034355 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2022-01-26

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Calmangafodipir (5 µmol/kg)

PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a solution in 20 mL single dose glass vials.

OTHER

Placebo

Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a solution in 20 mL single dose glass vials.

Sponsors & Collaborators

  • Solasia Pharma K.K.

    collaborator INDUSTRY

  • Egetis Therapeutics

    lead INDUSTRY

Principal Investigators

  • Stefan Carlsson, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034355 on ClinicalTrials.gov