Trials Sponsors Conditions Drugs Pricing

Conditions

Chemotherapy-induced Peripheral Neuropathy Colorectal Cancer

Keywords

colorectal cancercancerperipheral neuropathyneuropathy

Outcome Measures

Primary Outcomes (1)

Moderate or Severe Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN)
Percentage of patients (with moderate or severe chronic CIPN) scoring 3 or 4 in at least 1 of the first 4 items of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-13-item subscale (FACT/GOG-NTX-13; i.e., FACT/GOG-NTX-4) 9 months after the first dose of IMP (i.e. PledOx or placebo administered on Day 1, Cycle 1 of mFOLFOX6 chemotherapy). The FACT/GOG-13 questionnaire includes 13 items that measure the severity and impact of symptoms of neurotoxicity over the past 7 days. Patients rate each item as 0 ("not at all"), 1 (" a little bit"), 2 ("somewhat"), 3 ("quite a bit") or 4 ("very much"). These 13 items are summed to create a total score, ranging from 0 to 52, with a higher score representing a worse outcome. The FACT/GOG-NTX-4 is a 4 item subscale targeting numbness, tingling or discomfort in hands and/or feet.
9 months

Secondary Outcomes (7)

Mild, Moderate or Severe Chronic Chemotherapy Induced Peripheral Neuropathy
9 months
Sensitivity to Touching Cold Items
Baseline and 8 weeks
Cumulative Dose of Oxaliplatin During Chemotherapy
9 months
Vibration Sensitivity on the Lateral Malleolus
Baseline and 9 months
Worst Pain in Hands or Feet
Baseline and 9 months
+2 more secondary outcomes

Study Arms (2)

PledOx (5 µmol/kg)

EXPERIMENTAL

Calmangafodipir 5 µmol/kg

Drug: Calmangafodipir (5 µmol/kg)

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride in 20 mL vials

Other: Placebo

Interventions

Calmangafodipir (5 µmol/kg)Drug

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.

Also known as: PledOx

PledOx (5 µmol/kg)

PlaceboOther

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed informed consent form before any study related assessments and willing to follow all study procedures.
Male or female aged ≥18 years.

Sponsors & Collaborators

Solasia Pharma K.K.
Industrycollaborator
Egetis Therapeutics AB (publ)
Industrylead

Study Sites (65)

Onze-Lieve-Vrouwziekenuis Aalst

Aalst, Belgium

Imelda GI Clinical Research Center

Bonheiden, Belgium

Cliniques Universitaires St-Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

CHU Liège

Liège, Belgium

AZ Sint Maarten

Mechelen, Belgium

AZ Delta

Roeselare, Belgium

Related Publications (1)

Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.
PMID: 36308441DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsPeripheral Nervous System Diseases

Interventions

N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeuromuscular Diseases

Results Point of Contact

Title: Kristina Sjoblom Nygren
Organization: Egetis Therapeutics AB

Study Officials

Stefan Carlsson, MD
Chief Medical Officer
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

301 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details: Double-blind, placebo-controlled
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

July 26, 2019

Study Stopped

Preventive Treatment of OxaLiplatin Induced peripherAl neuRopathy in Adjuvant Colorectal Cancer

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

PledOx (5 µmol/kg)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (65)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations