186
Participants
Start Date
September 30, 2012
Primary Completion Date
March 31, 2016
Study Completion Date
December 31, 2016
PledOx (2 µmol/kg)
PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
PledOx (5 µmol/kg)
PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles
PledOx (10 µmol/kg)
PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles
Placebo (0,9% NaCl)
Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
S. Khechinashvili University Hospital, Tbilisi
"MHAT Serdika EOOD, Department of Medical Oncology", Sofia
"UMHAT Tzaritza Joanna-ISUL EAD, Clinic of Medical Oncology", Sofia
SHATO EAD, Sofia, Clinic of Chemotherapy, Sofia
Complex Oncology Center-Plovdiv EOOD, Department of Medical Oncology and oncology diseases in gastroenterology, Plovdiv
Odense Universitetshospital, Klinisk Forsknings Enhed, Onkologisk Afdelig R, Odense
LTD Clinic Medina, Batumi
Aalborg University Hospital, Dept of Oncology, Clinical Research Unit, Aalborg
Complex Oncology Center-Shumen EOOD, Department of Medical Oncology, Shumen
Institute for Oncology and Radiology of Serbia, Clinic for Medical Oncology, Belgrade
Military Medical Academy, Gastroenterology department, Belgrade
Clinical Hospital Center Zemun, Insitute for Oncology, Belgrade
Center for Cancer and Blood Disorders, Bethesda
Clinical Center Kragujevac, Center for Oncology, Kragujevac
Associates in Oncology & Hematology, Chattanooga
Wellmont Medical Associates Oncology and Hematology, Kingsport
Sahlgrenska/Östra sjukhuset, Gothenburg
HELIOS Klinikum Wuppertal, Klinik für Hämatologie und Onkologie, Wuppertal
St. Josef-Hospital -Universitätsklinik Ruhr-Universität Bochum, Leitende Ärztin der Abt. für Hämatologie und Onkologie, Medizinische Klinik I, Bochum
The University of Texas, Health Science Center at San Antonio, San Antonio
Gävle sjukhus, Oncology unit, Gävle
Benaroya Research Institute @ Virginia Mason, Seattle
Moores UCSD Cancer Center, La Jolla
Resaerch Institte of Clinical Medicine, Tbilisi
"JSC Neo Medi", Tbilisi
"LTD High Technology Medical Center University Clinic", Tbilisi
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie -Onkologie, Dresden
Centro Hospitalar do Baixo Vouga, E.P.E. (Hospital Infante D. Pedro), Oncologia Médica, Aveiro
Hospital de Braga, Oncologia Médica, Braga
Instituto Português de Oncologia do Porto, Francisco Gentil, E.P.E., Oncologia Médica, Porto
Universitetssjukhuset i Linköping, Linköping
Karolinska Sjukhuset, Stockholm
Akademiska Sjukhuset, Uppsala
Lead Sponsor
Collaborators (1)
Pharma Consulting Group AB
INDUSTRY
Egetis Therapeutics
INDUSTRY