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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 (9)

Mild, Moderate or Severe Chronic Chemotherapy Induced Peripheral Neuropathy (CIPN)
9 months

Study Arms (3)

PledOx (2 µmol/kg)

EXPERIMENTAL

Calmangafodipir (2 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.

Drug: Calmangafodipir (2 µmol/kg)

PledOx (5 µmol/kg)

EXPERIMENTAL

Calmangafodipir (5 µmol/kg) on day 1 every two weeks to patients as an intravenous infusion, combined with mFOLFOX6 chemotherapy.

Drug: Calmangafodipir (5 µmol/kg)

Placebo

PLACEBO COMPARATOR

Placebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.

Study Sites (98)

California Cancer Associates

Fresno, California, 93720, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Willis-Knighton Cancer Center

Shreveport, Louisiana, 71103, United States

Mercy Clinic - Cancer & Hematology

Springfield, Missouri, 65804, United States

Mercy Clinic Oncology and Hematology

St Louis, Missouri, 63141, United States

CHI St Francis Cancer Treatment Center

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 NeoplasmsNeoplasm MetastasisNeoplasms

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 DiseasesNeoplastic Processes

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: This is a Phase 3, multicenter, double-blind, placebo-controlled study to establish the efficacious dose of PledOx in prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by oxaliplatin. Patients with metastatic colorectal cancer (mCRC), who are indicated for first-line modified FOLFOX6 (mFOLFOX6) chemotherapy for at least 3 months, without any pre-planned treatment breaks, will be randomized in a 1:1:1 ratio, stratified by region (Asia, non-Asia) and PK sub-study (yes, no) to one of three treatment arms: * Arm A: PledOx (2 µmol/kg) + mFOLFOX6 chemotherapy * Arm B: PledOx (5 µmol/kg) + m * Arm C: Placebo + mFOLFOX6 chemotherapy

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Study Stopped

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

Brief Summary

Registry Overview

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First Posted

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Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

PledOx (2 µmol/kg)

PledOx (5 µmol/kg)

Placebo

Interventions

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Study Sites (98)

Related Publications (1)

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