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Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)

NCT03654729 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2021-12-17

Study results available
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Summary

This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

Conditions

Interventions

DRUG

Calmangafodipir (2 µmol/kg)

Solution in 20 mL single dose glass vials

DRUG

Calmangafodipir (5 µmol/kg)

Solution in 20 mL single dose glass vials

DRUG

Placebo

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
2018-11-07
Primary Completion
2020-08-31
Completion
2020-08-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03654729 on ClinicalTrials.gov