A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Advanced Metastatic (Stage IV) Colorectal Cancer

In brief

The present trial is designed to determine whether pre-treatment with PledOx lowers the frequency and severity of side effects from FOLFOX6 administration in patients with metastatic colorectal cancer. The efficacy of PledOx will be assessed when added to FOLFOX6 chemotherapy as first line treatment of metastatic colorectal cancer. This study was performed in multiple parts/phases. Part 1 was an open dose-escalation study with the doses 2, 5 and 10 micromol/kg of calmangafodipir. No study outcomes were planned for this part. In part 2a, participants randomly received either Placebo, 2 or 10 micromol/kg of calmangafodipir. In part 2b, participants randomly received either Placebo, 2 or 5 micromol/kg of calmangafodipir. The overall intent of the study was to compare the effect of antioxidant agent PledOx against placebo in one of three different doses/combinations (2 micromol/kg, 5/10 micromol/kg, 2/5/10 micromol/kg vs. placebo, in the first 8 cycles of FOLFOX6 treatment

Key facts

Study ID

NCT01619423

Run by

Egetis Therapeutics

People needed

186

Starts

2012-09-01

Expected to finish

2016-12-01

Last updated by the study team

2018-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Advanced metastatic colorectal (stage IV) cancer verified by biopsy
• Patients may have received up to three previous treatment lines of chemotherapy, which may include fluoropyrimidine, irinotecan and targeted therapies. The last dose of antitumor drug must be given at least 4 weeks prior to inclusion and all toxicity (except alopecia and fatigue) resolved. Patients may also be chemotherapy-naïve, have received prior adjuvant treatment but no previous treatment with oxaliplatin
• CT-scan or MRI of thorax, abdomen and pelvis; within ≤4 weeks before start of chemotherapy
• Evaluable disease and one measurable site of disease according to RECIST 1.1 criteria (at least 10mm for CT-scan or MRI)
• Neurological examination with no significant pathological findings
• ≥18 years
• WHO performance status 0≤2 and Life expectancy ≥ 3 months
• Adequate haematological function, Hb ≥ 100 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
• Adequate renal and hepatic functions: creatinine clearance >50 cc/min, total bilirubin ≤ 1.5 times ULN, ASAT and ALAT ≤ 3 times ULN (ASAT and ALAT ≤ 5 times ULN in case of liver metastases)
• INR ≤1.5 times ULN, unless receiving therapeutic anticoagulation
• Negative pregnancy test for females of child-producing potential
• Written informed consent given

You may not qualify if…

• Tumours other than colorectal adenocarcinomas (within the previous 5 years) except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix
• Evidence of central nervous system metastases
• Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn's disease or ulcerative colitis
• History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to Day 1 of treatment and serious arrhythmias requiring medication for treatment
• Prolonged QTC interval >450 msec
• Known history of stroke or cerebrovascular accident in the past six (6) months
• Severe diarrhoea
• Chronic infection or uncontrolled serious illness causing immunodeficiency
• Any uncontrolled serious illness or medical condition
• Received mangafodipir at any time
• Welders, mine workers or other workers in occupations (current or past) where high manganese exposure is likely
• Pre-existing neurodegenerative disease (Parkinson's, Alzheimer's, Huntington's etc.) or neuromuscular disorder (Multiple sclerosis, Amyotrophic lateral sclerosis, Polio, hereditary neuromuscular disease)
• Major psychiatric disorder (major depression, psychosis)
• Participation in another clinical study with an investigational medicinal product within 1 month prior to inclusion.
• Blood manganese concentration values >18.3 μg/L at screening

Where it is running

• Moores UCSD Cancer Center — La Jolla, California, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Associates in Oncology & Hematology — Chattanooga, Tennessee, United States
• Wellmont Medical Associates Oncology and Hematology — Kingsport, Tennessee, United States
• The University of Texas, Health Science Center at San Antonio — San Antonio, Texas, United States
• Benaroya Research Institute @ Virginia Mason — Seattle, Washington, United States
• Complex Oncology Center-Plovdiv EOOD, Department of Medical Oncology and oncology diseases in gastroenterology — Plovdiv, Bulgaria
• Complex Oncology Center-Shumen EOOD, Department of Medical Oncology — Shumen, Bulgaria
• MHAT "Serdika" EOOD, Department of Medical Oncology — Sofia, Bulgaria
• UMHAT "Tzaritza Joanna-ISUL" EAD, Clinic of Medical Oncology — Sofia, Bulgaria
• SHATO EAD, Sofia, Clinic of Chemotherapy — Sofia, Bulgaria
• Aalborg University Hospital, Dept of Oncology, Clinical Research Unit — Aalborg, Denmark
• Odense Universitetshospital, Klinisk Forsknings Enhed, Onkologisk Afdelig R — Odense, Denmark
• LTD Clinic Medina — Batumi, Georgia
• Resaerch Institte of Clinical Medicine — Tbilisi, Georgia
• JSC "Neo Medi" — Tbilisi, Georgia
• LTD " High Technology Medical Center University Clinic" — Tbilisi, Georgia
• S. Khechinashvili University Hospital — Tbilisi, Georgia
• St. Josef-Hospital -Universitätsklinik Ruhr-Universität Bochum, Leitende Ärztin der Abt. für Hämatologie und Onkologie, Medizinische Klinik I — Bochum, Germany
• BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie -Onkologie — Dresden, Germany
• HELIOS Klinikum Wuppertal, Klinik für Hämatologie und Onkologie — Wuppertal, Germany
• Centro Hospitalar do Baixo Vouga, E.P.E. (Hospital Infante D. Pedro), Oncologia Médica — Aveiro, Portugal
• Hospital de Braga, Oncologia Médica — Braga, Portugal
• Instituto Português de Oncologia do Porto, Francisco Gentil, E.P.E., Oncologia Médica — Porto, Portugal
• Institute for Oncology and Radiology of Serbia, Clinic for Medical Oncology — Belgrade, Serbia

Full record on ClinicalTrials.gov

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