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

PHASE3TerminatedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

November 7, 2018

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Colorectal CancerChemotherapy-induced Peripheral Neuropathy
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

Trial Locations (98)

10461

Montefiore Medical Research, The Bronx

11042

Monter Cancer Center, Lake Success

32763

Mid Florida Hematology and Oncology Center, Orange City

63141

Mercy Clinic Oncology and Hematology, St Louis

65804

Mercy Clinic - Cancer & Hematology, Springfield

67214

Cancer Center of Kansas, Wichita

68803

CHI St Francis Cancer Treatment Center, Grand Island

71103

Willis-Knighton Cancer Center, Shreveport

76508

Scott & White Vasicek Cancer Treatment Center, Temple

93720

California Cancer Associates, Fresno

08822

Hunterdon Hematology Oncology, Flemington

Unknown

Onze-Lieve-Vrouwziekenuis Aalst, Aalst

Imelda GI Clinical Research Center, Bonheiden

Cliniques Universitaires St-Luc, Brussels

UZ Gent, Ghent

CHU Liège, Liège

AZ Sint Maarten, Mechelen

AZ Delta, Roeselare

CHU UCL Namur - Site Godinne, Yvoir

Nemocnice Benesov, Benešov

Nemocnice Horovice, Hořovice

Nemocnice Na Pleši, Nová Ves pod Pleší

General University Hospital, Prague

Hospital Na Bulovce, Prague

Onkologická Klinika 1. Lf Uk A Tn, Prague

CHRU de Brest - Hôpital Morvan, Brest

Clinique Pasteur-Lanroze, Brest

Centre Hospitalier Départemental de Vendée - Unité de recherche clinique, La Roche-sur-Yon

Centre Oscar Lambret, Lille

Hôpital Edouard Herriot - HCL, Lyon

Hôpital Nord Franche-Comté Site du Mittan, Montbéliard

Institut de Cancérologie de l'Ouest, Nantes

Hopital l'Archet, CHU de Nice, Nice

Hôpital Robert Debré, Reims

Centre Hospitalier Privé Saint-Grégoire, Saint-Grégoire

Clinique Ste Anne, Strasbourg

Hopitaux Universitaires de Strasbourg, Strasbourg

Hämatolgisch-onkologische Praxis Augsburg, Augsburg

Onkozentrum Dresden, Dresden

Universitätsklinikum Carl Gustav Carus, Dresden

Agaplesion Markus Krankenhaus, Frankfurt

Onkodok GmbH, Gütersloh

Klinikum Neuperlach, München

Queen Mary Hospital, Hong Kong

Országos Onkológiai Intézet, Budapest

Semmelweis Egyetem, Budapest

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Miskolc

Tolna Megyei Balassa Janos Korhaz, Szekszárd

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet, Szolnok

IRCCS Candiolo, Candiolo

Oncologia Istituti Ospitalieri, Cremona

Irccs Irst, Meldola - FC

Azienda Ospedaliero - Universitaria di Modena Policlinico, Modena

Hospital San Gerardo, Monza

Istituto Nazionale Tumori, Napoli

IRCCS Policlinico San Matteo, Pavia

Ospedale degli infermi, Ponderano

Ospedale S. Maria delle Croci - Ravenna, Ravenna

IRCCS azienda Ospedaliera S Maria Nuova, Reggio Emilia

San Camillo Forlanini Hospital, Rome

Casa Sollievo della Sofferenza, San Giovanni Rotondo

Kansai Rosai Hospital, Hyōgo

Hallym University Sacred Heart Hospital, Anyang-si

Dong-A University Hospital, Busan

Chonnam National University Hwasun Hospital, Gwangju

Seoul National University Bundang Hospital, Seongnam-si

Korea University Guro Hospital, Seoul

Seoul National University Hospital, Seoul

Hospital de La Santa Creu I Sant Pau, Barcelona

L´Hospitalet de Llobregat (Barcelona), Barcelona

Vall d'hebron university hospital, Barcelona

Complejo Hospitalario de Jaén, Jaén

Centro Integral Oncologico Clara Campal, Madrid

H.G.U.Gregorio Marañón, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Puerta de Hierro, Majadahonda

Hospital Universitario Virgen Macarena, Seville

Hospital Quironsalud Valencia, Valencia

Hospital Miguel Servet, Zaragoza

KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

CMMC: Chi Mei Medical Center, Tainan City

NCKUH: National Cheng Kung University Hospital, Tainan City

541-8567

Osaka International Cancer Institute, Osaka-shi, Osaka

470-1192

Fujita Health University Hospital, Aichi

812-8582

Kyushu University Hospital, Fukuoka-shi, Fukuoka

814-0133

Fukuoka University Hospital, Fukuoka-shi, Fukuoka

216-8511

St. Marianna University School of Medicine Hospital, Kanagawa

464-8681

Aichi Cancer Center Hospital, Nagoya-shi, Aichi

565-0871

Osaka University Hospital, Osaka

540-0006

National Hospital Organization Osaka National Hospital, Osaka-shi, Osaka

065-0033

Sapporo Medical University Hospital, Sapporo-shi, Hokkaido

411-8777

Shizuoka Cancer Center, Shizuoka

135-8550

The Cancer Institute Hospital Of JFCR, Tokyo

SW3 6JJ

Royal Marsden Hospital, London

NE29 8NH

North Tyneside General Hospital, North Shields

HA6 2RN

Mount Vernon Cancer Centre, Northwood

SM2 5PT

The Royal Marsden Hospital (Surrey), Sutton

YO61 8HE

York Teaching Hospital, York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Solasia Pharma K.K.

INDUSTRY

lead

Egetis Therapeutics

INDUSTRY

NCT03654729 - Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M) | Biotech Hunter | Biotech Hunter