360
Participants
Start Date
June 30, 2006
Primary Completion Date
August 31, 2008
Study Completion Date
August 31, 2008
GV1001
0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.
Gemcitabine (Chemotherapy)
Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.
Erasms University Hospital, Brussels
Sorlandet Hospital, Senter for Kreftbehandling, Kristiansand
Odense Universitetshospital, Onkologisk afd. R, Odense
Hospital De Jolimont, Brussels
Ghent University Hospital, Digestive Oncology, Ghent
Oncologie Medicale, Clinic Pasteur, Évreux
Hospital Universitario Gregorio Marañón, Departamento de Oncología, Madrid
Clínica Puerta de Hierro, Departamento de Oncología, Madrid
Hospital Universitario La Paz, Departamento de Oncología, Madrid
Carolinas Hematology Oncology Associates, Charlotte
H. Monteprincipe, Madrid
Fundaciόn Hospital de Alcorcόn, Unidad de Oncología, Madrid
HRU Carlos Haya, Medical Oncology Unit, Málaga
Palm Beach Cancer Institute, West Palm Beach
The Center for Hematology-Oncology, Boca Raton
Tampa General Hospital Usf Digestive Disorders Centre, Tampa
Clinic Saint Vincent, Saint-Grégoire
University of South Alabama Mitchell Cancer Institute, Mobile
"Hospital G.B. Rossi, Surgical and Gastroenterological Dept. Borgo Roma", Verona
Azienda Ospedaliera, Arcispedale S. Maria Nuova, Reggio Emilia
Toledo Community Hospital Oncology Program, Toledo
Oncologie Médicale, Centre Cathrine de Siennes, Nantes
Gabrail Cancer Center, Canton
Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin, Angers
"Hospital Careggi, Medical Oncology", Florence
Oncologie Midicale CHR Lorient, Lorient
Service de Medicine Interne, CHRU de Lille, Lille
Billings Clinic, Billings
"Medical Oncology, University Politecnica Delle Marche, Oncologia Medica Universita", Ancona
Oncology Hematology Associates of Central Illinois, PC, Peoria
Hematology Oncology Specialists, Covington, Covington
Genesis Cancer Center, Hot Springs
Service de Cancerologie, Hospital Europeen Georges Pompidou, Paris
Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas, Dallas
Mary Crowley Medical Research Center, Worth St., Dallas
Oncology Consultants, PA, Houston
Southwest Regional Cancer Center, Austin
Portneuf Cancer Center, Pocatello
Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale, Moreau
"Policlinico Universitario Mater Domini, Unita Oncologia", Catanzaro
Scripps Clinic Torrey Pines, La Jolla
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage
Berskhire Hematology Oncology PC, Pittsfield
St George Hospital, Department of Medical Oncology, Kogarah
Westmead Hospital, Dept. of Medical Oncology and Palliative Care, Westmead
The Townsville Hospital, Townsville Cancer Centre, Douglas
Flinders Medical Centre, Medical Oncology - Clinical Trials, Bedford Park
Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital, Woodville South
Sir Charles Gairdner Hospital, Nedlands
Wesley Research Institute Limited, Auchenflower QLD
Oncology Department, Århus Hospital, Aarhus
Oncology Department, Herlev Hospital, Herlev
Hepatogastroenterology Dpt, University Hospital Center of Grenoble, Grenoble
Medical Oncology Dpt, Armoricaine Private Hospital of Radiology, Saint-Brieuc
Oncology Trials Unit, Cork University Hospital, Cork
Cancer Clinical Trials Unit, Beaumont Hospital, Dublin
Cancer Research Unit, Mater Misericordlae University Hospital, Dublin
Department of Medical Oncology, Amnch, Dublin
Oncology Research Team, Mater Private University Hospital, Dublin
Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology, Bergen
Department of Oncology, University Hospital of Northern-Norway, Tromsø
Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University, Lodz
Medical Oncology Department, General Hospital of Baza, Granada
Medical Oncology Department, Virgen de Las Nieves Hospital, Granada
Oncology Department, Clinic Universitary Hospital, Málaga
Digestive Unit, Universitary Hospital Virgen de La Macarena, Seville
Department of Oncology, Malmö University Hospital, Malmo
Royal Hobart Hospital, Centre for Clinical Research, Hobart
Box Hill Hospital, ECRU Oncology, Box Hill
The Alfred Hospital, Medical Oncology Unit, Melbourne
Fremantle Hospital, Haemtology Department, Fremantle
Mount Medical Centre, Perth Oncology, Perth
Royal Perth Hospital, Department of Medical Oncology, Perth
VU University Medical Center, Amsterdam
Ullevål Universitetssykehus, Gastrokirurgisk afd., Oslo
Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych, Bialystok
W.S2.Z, Krolewiecka, Elblag
Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii, Krakow
Zaklad Opieki Zdrowotnej MSWiA, Olsztyn
Centrum Onkologii, Wosewodzki Osrodek Onkologii, Opole
Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii, Wroclaw
Hospital Clinic I Provincial De Barcelona, Barcelona
Sahlgrenska Hospital, Head Division for Upper GI Surgery, Gothenburg
University Hospital, Department Of surgery and Gasterenterology, Lund
Karolinska Institute / Hospital Solna, Department of Oncology, Stockholm
Department of Oncology, Karolinska Universitetssjukhuset, Stockholm
Lead Sponsor
Collaborators (3)
ICON Clinical Research
INDUSTRY
ORION Clinical Services
INDUSTRY
CIRION Central Laboratory
UNKNOWN
Dorevitch
UNKNOWN
Syneos Health
OTHER
Pharmexa A/S
INDUSTRY