NCT04034355

Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Egetis Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 µmol/kg) + mFOLFOX6 chemotherapy * Arm B: Placebo + mFOLFOX6 chemotherapy Before March 2nd., 2020, the investigational medicinal product (IMP; i.e. PledOx or placebo) was administered by an intravenous (i.v.) infusion on the first day of each chemotherapy cycle. IMP was not to be administered if mFOLFOX6 was not given to the patient. If a patient later discontinues oxaliplatin, treatment with 5-FU/folinate and IMP may be continued. As of March 2nd., all patients have to stop IMP but may continue mFOLFOX6.

Conditions

• Colorectal Cancer
• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-07
• Primary completion: 2020-08-31
• Completion: 2020-08-31
• First posted: 2019-07-26
• Last updated: 2022-01-26
• Results posted: 2022-01-26

Locations

65 sites across 10 countries: Belgium, Czechia, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom