Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654729
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Solasia Pharma K.K.
Information provided by (Responsible Party):
PledPharma AB

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Chemotherapy-induced Peripheral Neuropathy Drug: Calmangafodipir (2 µmol/kg) Drug: Calmangafodipir (5 µmol/kg) Drug: Placebo Phase 3

Detailed Description:
Oxaliplatin, in combination with 5-fluorouracil plus folinate (or capecitabine), has increased survival in stage III colorectal cancer and prolonged life in stage IV patients, but its use is compromised because of severe toxicity. Chemotherapy-induced peripheral neuropathy (CIPN) is the most problematic dose-limiting toxicity of oxaliplatin. No treatments have been clinically proven to prevent CIPN. There is a body of evidence that CIPN is caused by cellular oxidative stress. Clinical and preclinical data suggest that the manganese chelate and superoxide dismutase mimetic mangafodipir (MnDPDP) and calmangafodipir (Ca4Mn(DPDP)5) are efficacious inhibitors of CIPN and other conditions caused by cellular oxidative stress, without interfering negatively with the tumoricidal activity of chemotherapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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 prior oxaliplatin exposure (yes/no), to one of three treatment arms:

  • Arm A: PledOx (2 µmol/kg) + mFOLFOX6 chemotherapy
  • Arm B: PledOx (5 µmol/kg) + mFOLFOX6 chemotherapy
  • Arm C: Placebo + mFOLFOX6 chemotherapy

The Investigational Medicinal Product, IMP (i.e. PledOx or placebo) will be administered by an intravenous infusion on the first day of each chemotherapy (mFOLFOX6) cycle.

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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 Patients With First-line mCRC
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: PledOx (2 µmol/kg)
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)
Bright yellow, clear solution in 20 mL colourless, single dose, glass vial
Other Name: PledOx

Experimental: PledOx (5 µmol/kg)
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)
Bright yellow, clear solution in 20 mL colourless, single dose, glass vial
Other Name: PledOx

Placebo Comparator: Placebo
Placebo will be given to patients as an intravenous infusion, on top of mFOLFOX6 chemotherapy.
Drug: Placebo
Bright yellow, clear solution in 20 mL amber, single dose, glass vial




Primary Outcome Measures :
  1. Moderate or severe chronic chemotherapy induced peripheral neuropathy (CIPN) [ Time Frame: 9 months ]
    Proportion of patients (with moderate or severe chronic CIPN) scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOG-NTX-13 (i.e., FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, 9 months after the first dose of IMP (i.e. PledOx or placebo administered on Day 1, Cycle 1 of mFOLFOX6 chemotherapy).


Secondary Outcome Measures :
  1. Mild, moderate or severe chronic chemotherapy induced peripheral neuropathy (CIPN) [ Time Frame: 9 months ]
    Proportion of patients (with mild, moderate or severe chronic CIPN) scoring 2, 3, or 4, in at least 1 of the first 4 items of the FACT/GOG-NTX-13 (i.e. FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, 9 months after the first dose of IMP.

  2. Sensitivity to touching cold items [ Time Frame: 6 weeks ]
    Mean change from baseline in sensitivity to touching cold items on day 2, Cycle 4 of mFOLFOX6 chemotherapy, as assessed by the Cold Sensitivity Questionnaire (measuring sensitivity when touching or swallowing cold objects/fluid). 10 point scale from 0 meaning no sensitivity/discomfort at all to 10 meaning sensitivity/discomfort as bad as it can be.

  3. Cumulative dose of oxaliplatin during chemotherapy [ Time Frame: 9 months ]
    Mean cumulative dose of oxaliplatin administered per patient during mFOLFOX6 chemotherapy, 9 months after the first dose of IMP.

  4. Vibration sensitivity on the lateral malleolus [ Time Frame: 9 months ]
    Mean change from baseline in vibration sense, on the lateral malleolus (left and right), using a graduated tuning fork, at 9 months after the first dose of IMP.

  5. Worst pain in hands or feet [ Time Frame: 9 months ]
    Mean change from baseline in worst pain in hands or feet in the past week, using the Pain Assessment (Numerical Rating Scale (NRS)), at 9 months after the first dose of IMP. The NRS is a 10 point scale with 0 as no pain at all and 10 as pain as bad as you can imagine and evaluates the intensity of pain in hands and feet during the past week. A higher value means worse outcome.

  6. Functional impairment (in the non-dominant hand) [ Time Frame: 9 months ]
    Mean change from baseline in the time to complete the grooved Pegboard with the non-dominant hand, at 9 months after the first dose of IMP.

  7. Sustained efficacy on prevention of CIPN during long-term follow-up [ Time Frame: 12, 15, 18, 21 and 24 months ]
    Proportion of patients scoring 3 or 4 in at least 1 of the first 4 items of the FACT/GOGNTX-13 (i.e. FACT/GOG-NTX-4), targeting numbness, tingling or discomfort in hands and/or feet, 12, 15, 18, 21 and 24 months after the first dose of IMP.

  8. Overall response rate (ORR) [ Time Frame: 12 and 24 months ]
    ORR, according to RECIST v1.1

  9. Progression-free survival (PFS) [ Time Frame: 12 and 24 months ]
    PFS

  10. Overall survival (OS) [ Time Frame: 36 months ]
    Time to death (OS)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form before any study related assessments and willing to follow all study procedures.
  • Male or female aged >=18 years.
  • Non-resectable metastatic (stage IV) CRC, pathologically confirmed adenocarcinoma of the colon or rectum.
  • No prior chemotherapy (within the previous 12 months) and/or biologic/targeted therapy for mCRC.
  • Measurable disease according to RECIST 1.1.
  • Patient indicated for at least 3 months of oxaliplatin-based chemotherapy (without any pre-planned treatment breaks) and without any clinically observed neurological disorders.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematological parameters: hemoglobin >=100 g/L, absolute neutrophil count (ANC) >=1.5 x 10^9 /L, platelets >=100 x 10^9 /L.
  • Adequate renal function: creatinine clearance >50 cc/min using the Cockroft and Gault formula or measured.
  • Adequate hepatic function: total bilirubin <=1.5 times the upper limit of normal (ULN) (except in the case of known Gilbert's syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3 times ULN (AST and ALT <=5 times ULN in case of liver metastases).
  • Baseline blood manganese (Mn) level <2.0 times ULN.
  • For patients with a history of diabetes mellitus, HbA1c <=7%.
  • Negative pregnancy test for females of child-bearing potential.
  • For men and females of childbearing potential, use of adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) while on study drug and for at least 6 months after completion of study therapy.

Exclusion Criteria:

  • Any unresolved toxicity by Common Terminology Criteria for Adverse Events Version (CTCAE v4.03) > Grade 1 from previous anti-cancer therapy (including radiotherapy), except alopecia.
  • Any grade of neuropathy from any cause.
  • Any prior oxaliplatin-based chemotherapy <1 year before the randomization.
  • Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, unresolved bowel obstruction, hepatic or renal disease).
  • Chronic infection or uncontrolled serious illness causing immunodeficiency.
  • A surgical incision that is not healed.
  • Significant hemorrhage (>30 mL/bleeding episode in previous 3 months), hemoptysis (>5 mL fresh blood in previous 4 weeks) or thrombotic event (including transient ischemic attack) in the previous 12 months if the patient is expected to receive anti-VEGF/VEGFR therapy.
  • Known hypersensitivity to any of the components of mFOLFOX6 and, if applicable, biological therapies to be used in conjunction with the chemotherapy regimen or any of the excipients of these products.
  • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within 5 years, unless the patient has been disease free for that other malignancy for at least 2 years.
  • Known dihydropyrimidine dehydrogenase deficiency.
  • Pre-existing neurodegenerative disease (e.g., Parkinson's, Alzheimer's, Huntington's) or neuromuscular disorder (e.g., multiple sclerosis, amyotrophic lateral sclerosis, polio, hereditary neuromuscular disease).
  • Major psychiatric disorder (major depression, psychosis), alcohol and/or drug abuse.
  • Patients with a history of second or third degree atrioventricular block or a family heredity.
  • A history of a genetic or familial neuropathy.
  • Treatment with any investigational drug within 30 days prior to randomization.
  • Pregnancy, lactation or reluctance to using contraception.
  • Any other condition that, in the opinion of the Investigator, places the patient at undue risk.
  • Previous exposure to mangafodipir or calmangafodipir.
  • Welders, mine workers or other workers in occupations (current or past) where high manganese exposure is likely.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654729


Contacts
Layout table for location contacts
Contact: Stefan Carlsson, MD +46709641009 stefan.carlsson@pledpharma.se

Locations
Hide Hide 107 study locations
Layout table for location information
United States, California
PCR Oncology Recruiting
Arroyo Grande, California, United States, 93420
Contact: David Palchak, MD    805-474-9143      
California Cancer Associates Recruiting
Fresno, California, United States, 93720
Contact: Steven Hager, BS, DO    559-326-1222      
Marin Cancer Care Recruiting
Greenbrae, California, United States, 94904
Contact: Peter Eisenberg, MD, FACP    415-925-5000      
St Joseph Heritage Healthcare Recruiting
Santa Rosa, California, United States, 95405
Contact: Thomas Stanton, MD    707-521-3826      
United States, Florida
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Mike Cusnir, MD    305-674-2625 ext 55861      
Mid Florida Hematology and Oncology Center Recruiting
Orange City, Florida, United States, 32763
Contact: Santosh Nair, MD    386-774-1223      
United States, Iowa
PMG Research, Inc. d/b/a PMG Research of McFarland Clinic Recruiting
Ames, Iowa, United States, 50010
Contact: Debra M Prow, MD    515-956-4159      
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R Dakhil, MD, FACP    316-262-4467      
United States, Louisiana
Willis-Knighton Cancer Center Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Nihar Patel, MD    318-212-8620      
United States, Missouri
Mercy Clinic Oncology and Hematology Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany Sleckman, MD    314-251-7057      
Mercy Clinic - Cancer & Hematology Recruiting
Springfield, Missouri, United States, 65804
Contact: Mohan Tummala, MD, MRCP    417-820-8099      
United States, Nebraska
CHI St Francis Cancer Treatment Center Recruiting
Grand Island, Nebraska, United States, 68803
Contact: David Crockett, MD    308-218-1022      
United States, New Jersey
Hunterdon Hematology Oncology Recruiting
Flemington, New Jersey, United States, 08822
Contact: Megan Shah, MD    908-237-2330 ext 2      
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Marcus Porcelli, MD    732-246-4882      
United States, New York
Montefiore Medical Research Recruiting
Bronx, New York, United States, 10461
Contact: Sanjay Goel, MD    516-470-6911      
Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Contact: James D'Olimpio, MD    516-734-8842      
United States, North Dakota
Sanford Medical Center Recruiting
Bismarck, North Dakota, United States, 58501
Contact: Peter Kurniala, MD    701-323-5741      
Trinity CancerCare Center Recruiting
Minot, North Dakota, United States, 58701
Contact: Patanit Watanaboonyakhet, MD    701-857-3535      
United States, Ohio
Hematology & Oncology Associates Recruiting
Canton, Ohio, United States, 44706
Contact: Mitchell Haut, MD    330-453-9993      
TriCounty Hematology and Oncology Associates Recruiting
Massillon, Ohio, United States, 44646
Contact: Nagaprasad Nagajothi, MD    330-489-1274      
United States, Oklahoma
Mercy Clinic Oncology and Hematology - McAuley Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Carla Kurkijan, MD         
United States, South Carolina
Charleston Hematology Oncology Associates Recruiting
Charleston, South Carolina, United States, 29403-5744
Contact: James Orcutt, MD    843-577-6957      
United States, South Dakota
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Jonathan Bleeker, MD    605-328-8000      
United States, Texas
Baylor Scott and White Recruiting
Temple, Texas, United States, 76508
Contact: Lucas Wong, MD, FACP    254-771-4828      
United States, Wisconsin
Mayo Clinic Health System- Franciscan Healthcare Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Jonathan Ticku, MD    608-785-0940      
Belgium
Onze-Lieve-Vrouwziekenuis Aalst Recruiting
Aalst, Belgium
Contact: Koen Hendrickx, MD    +32 09/282.03.76      
Imelda GI Clinical Research Center Recruiting
Bonheiden, Belgium
Contact: Pieter-Jan Cuyle, MD, PhD    +32 15 50 51 69      
Cliniques Universitaires St-Luc Recruiting
Brussels, Belgium
Contact: Marc Van den Eynde, MD    +32 02/764.51.06      
UZ Gent Recruiting
Gent, Belgium
Contact: Karen K Geboes, MD, PhD    +32 9 33.22.378      
CHU Liège Recruiting
Liege, Belgium
Contact: Elodie Gonne, MD    +32 4284 3552      
AZ Sint Maarten Recruiting
Mechelen, Belgium
Contact: Leen Mortier, MD    +32 474/59.38.57      
AZ Delta campus Wilgenstraat Recruiting
Roeselare, Belgium
Contact: Pieter Vandecandelaere, MD    +32 051/62.38.37      
CHU UCL Namur - Site Godinne Recruiting
Yvoir, Belgium
Contact: Lionel D'hondt, MD, PhD    +32 81.42.38.58      
Czechia
Nemocnice Benesov Recruiting
Benešov, Czechia
Contact: Martin Šmákal, MUDr    +420 603 268 133      
Nemocnice Horovice Recruiting
Hořovice, Czechia
Contact: Martin Šmákal, MUDr    +420 603 268 133      
Nemocnice Na Pleši Recruiting
Nová Ves Pod Pleší, Czechia
Contact: Katerina Jirsová, MD    +420 318 541 416      
General University Hospital Recruiting
Prague 2, Czechia
Contact: Michal Vocka, MD    +420 224 962219      
Hospital Na Bulovce Recruiting
Prague, Czechia
Contact: Petra Holeckova, MUDr, MBA, PhD    +420 604 243459      
Onkologická Klinika 1. Lf Uk A Tn Recruiting
Prague, Czechia
Contact: Eugen Kubala, MD    +420 261 083 733      
France
Clinique Pasteur-Lanroze Recruiting
Brest Cedex 2, France
Contact: Véronique Jestin - Le Tallec, MD    +33 .02 98 31 32 00      
Institut de Cancérologie Recruiting
Brest, France
Contact: Jean Philippe Metges, MD    +33 02 98 22 34 28      
Unité de Recherche Clinique - CHD Vendée Recruiting
La Roche-sur-Yon, France
Contact: Roger Faroux, MD    +33 2 51 44 61 68      
Centre Oscar Lambret Recruiting
Lille, France
Contact: Aurélien Carnot, MD    +33 32 0295942      
Hôpital Edouard Herriot - HCL Recruiting
LYON Cedex 03, France
Contact: Julien Forestier, MD    +33 04 72 11 97 38      
Hôpital Nord Franche-Comté Site du Mittan Recruiting
Montbéliard Cedex, France
Contact: Stefano Kim, MD    +33 3.84.98.35.70      
Institut de Cancérologie de l'Ouest Recruiting
Nantes, France
Contact: Judith Raimbourg, MD    +33 2 40 67 99 00      
Hopital l'Archet, CHU de Nice Recruiting
NICE Cedex 3, France
Contact: Delphine Ouvrier, MD    +33 4 92 03 62 87      
Centre Hospitalier Privé Saint-Grégoire Recruiting
Reims, France
Contact: Jerome Chamois, MD    +33 2-99-25-30-00      
Hôpital Robert Debré Recruiting
Saint-Grégoire, France
Contact: Olivier Bouche, MD    +33-326787172      
Clinique Ste Anne Recruiting
Strasbourg, France
Contact: Louis Marie Dourthe, MD    +33 03/88.45.47.00      
Hopitaux Universitaires de Strasbourg Recruiting
Strasbourg, France
Contact: Sebastian Serra, MD    +33 3 88 11 51 41      
Germany
Hämatolgisch-onkologische Praxis Augsburg Recruiting
Augsburg, Germany
Contact: Bernhard Heinrich, MD    +49 821 344650      
Onkozentrum Dresden Recruiting
Dresden, Germany
Contact: Thomas Göhler, MD    +49 351 795 255-0      
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany
Contact: Gunnar Folprecht, PhD    +49 (0) 351 458 4190      
Agaplesion Markus Krankenhaus Recruiting
Frankfurt, Germany
Contact: Claus Bolling, MD    +49 69 95332118      
Onkodok GmbH Recruiting
Gütersloh, Germany
Contact: Reinhard Depenbusch, MD    +49 5241 832 8100      
Klinikum Neuperlach Recruiting
München, Germany
Contact: Meinolf Karthaus, MD    +49 89 6210-2731      
Zentrum für Hämatologie und Onkologie Recruiting
Porta Westfalica, Germany
Contact: Enno Moorahrend, MD    +49 05 71 29 222      
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Ka-On Lam, MD,MBBS(HK),FRCR,FHKCR,FHKAM    +852 2255 4352      
Italy
IRCCS Candiolo Recruiting
Candiolo, Italy
Contact: Massimo Aglietta, MD    +39 11 9933628      
Oncologia Istituti Ospitalieri Recruiting
Cremona, Italy
Contact: Rodolfo Passalacqua, MD    +39 329 4069464      
Irccs Irst Recruiting
Meldola - FC, Italy
Contact: Giovanni Luca Frassineti, MD    +39 543 739100      
Hospital San Gerardo Recruiting
Monza, Italy
Contact: Raffaella Longarini, MD    +39 039 2339038      
Istituto Nazionale Tumori Recruiting
Napoli, Italy
Contact: Guglielmo Nasti, MD    +39 081 5903351      
IRCCS Policlinico San Matteo Recruiting
Pavia, Italy
Contact: Silvia Brugnatelli, MD    +39 0382 503689      
Ospedale degli infermi Recruiting
Ponderano, Italy
Contact: Myriam Paris, MD    +39 015 15157503      
Ospedale S. Maria delle Croci - Ravenna Not yet recruiting
Ravenna, Italy
Contact: Federico Cappuzzo, MD    39544285330      
IRCCS azienda Ospedaliera S Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: Maria Banzi, MD    +39 0522296858      
San Camillo Forlanini Hospital Recruiting
Rome, Italy
Contact: Stefano de Santis, MD, PhD    +39 06 58704739      
Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy
Contact: Evaristo Maiello, MD    +39 0882410640      
Japan
Osaka International Cancer Institute Recruiting
Osaka-shi, Osaka, Osaka, Japan, 541-8567
Contact: Naotoshi Sugimoto, MD    +81 6-6945-1181      
Fujita Health University Hospital Recruiting
Aichi, Japan, 470-1192
Contact: Hiroshi Matsuoka, MD    81 562 93-2139      
Kyushu University Hospital Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Contact: Eiji Oki, MD    81 92 641-1151      
Fukuoka University Hospital Recruiting
Fukuoka-shi, Fukuoka, Japan, 814-0133
Contact: Yoichiro Yoshida, MD    +81 92-801-1011      
Kansai Rosai Hospital Not yet recruiting
Hyōgo, Japan
Contact: Taishi Hata, MD. PhD    +81 6-6416-1221      
St. Marianna University School of Medicine Hospital Recruiting
Kanagawa, Japan, 216-8511
Contact: Yoshiki Horie, M.D.,Ph.D    +81 44 977-8111      
Aichi Cancer Center Hospital Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
Contact: Kei Muro, MD    81 52 762-6111      
National Hospital Organization Osaka National Hospital Recruiting
Osaka-shi, Osaka, Japan, 540-0006
Contact: Takeshi Kato, MD    81 6 6942-1331      
Osaka University Hospital Recruiting
Osaka, Japan, 565-0871
Contact: Taroh Satoh, M.D.,Ph.D    81 6 6879-5111      
Sapporo Medical University Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 065-0033
Contact: Ichiro Takemasa, M.D.,Ph.D, FACS    81 11 611-2111      
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 411-8777
Contact: Kentaro Yamazaki, M.D.,Ph.D    81 55 989-5222      
The Cancer Institute Hospital Of JFCR Recruiting
Tokyo, Japan, 135-8550
Contact: Kensei Yamaguchi, MD    81 3 3520-0111      
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang-si, Korea, Republic of
Contact: Dae Young Zang, MD    +82 31 380 4167      
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Contact: Sung Yong Oh, MD    +82 51 240 2808      
Chonnam National University Hwasun Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Sang-Hee Cho, MD    +82 61 379 7633      
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of
Contact: Kwen-Wook Lee, MD    +82 31 787 7037      
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sang Cheul Oh, MD    +82 2 2626 3060      
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Tae-You Kim, MD    +82-2-2072-3943      
Spain
Granvia de L´Hospitalet 199-203 Recruiting
Barcelona, Spain
Contact: Roser Velasco, MD    (+34) 932607500      
Hospital de La Santa Creu I Sant Pau Recruiting
Barcelona, Spain
Contact: David Paez, PhD, MSc    (+34) 935565631      
Vall d'hebron university hospital Recruiting
Barcelona, Spain
Contact: Elena Élez, PhD    +34 93 254 3450      
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain
Contact: Antonio Cubillo Gracian, PhD    (+34) 91 7500202      
H.G.U.Gregorio Marañón Recruiting
Madrid, Spain
Contact: Pilar García Alfonso, MD, PhD    (+34) 914269070      
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: Nuria Rodriguez Salas    +34 912071138      
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Spain
Contact: Antonio C Sanchez Ruiz, MD, PhD    (+34) 911917147      
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain
Contact: Juan J Reina Zoilo, MD    (34) 955 00 80 00      
Hospital Quironsalud Valencia Recruiting
València, Spain
Contact: Ricardo Yaya, MD    (+34) 961104620      
Hospital Miguel Servet Recruiting
Zaragoza, Spain
Contact: Vicente Alonso-Orduña, PhD    (34) 976 76 55 00      
Taiwan
KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Jaw-Yuan Wang, MD    +886-7-3121101 ext.5575      
CMMC: Chi Mei Medical Center Recruiting
Tainan, Taiwan
Contact: Cheng-Yao Lin, MD    +886-6-6226999 ext. 73132      
NCKUH: National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Yu-Min Yeh, MD    +886-6-2353535 ext.2389      
United Kingdom
Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
Contact: David Watkins, MB, BS    44 208 661 3833      
University College London Hospital Withdrawn
London, United Kingdom
North Tyneside General Hospital Recruiting
North Shields, United Kingdom, NE29 8NH
Contact: Michelle Cunnell, MD    44 191 2139918      
Mount Vernon Cancer Centre Recruiting
Northwood, United Kingdom, HA6 2RN
Contact: Andreas Polychronis, MBBCh, MRCP, PhD, FRCP    44 2038262058      
The Royal Marsden Hospital (Surrey) Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: David Watkins, MB, BS    44 208 661 3833      
York Teaching Hospital Recruiting
York, United Kingdom, YO61 8HE
Contact: Kim Last, MBBS, BSc, PhD, MRCP    44 1904 726488      
Sponsors and Collaborators
PledPharma AB
Solasia Pharma K.K.
Investigators
Layout table for investigator information
Study Director: Stefan Carlsson, MD Chief Medical Officer

Layout table for additonal information
Responsible Party: PledPharma AB
ClinicalTrials.gov Identifier: NCT03654729    
Other Study ID Numbers: PP06490
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PledPharma AB:
Metastatic
Colorectal
Cancer
Metastatic Colorectal Cancer
Oxaliplatin induced CIPN
CIPN
Oxaliplatin
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Peripheral Nervous System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases
Pyridoxal Phosphate
Oxaliplatin
Edetic Acid
Antineoplastic Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs