GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
NCT ID: NCT00358566
Last Updated: 2008-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
360 participants
INTERVENTIONAL
2006-06-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gemcitabine
Gemcitabine alone treatment.
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.
GV1001
GV1001 in sequential combination with Gemcitabine
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adequate hematological parameters:
Hemoglobin \>/= 9.5 g/dL \[SI units, 5.9 mmol/L\] WBC \>/= 3000/mm3 \[SI units, \>/= 3 x 109/L\] Platelets \>/= 100,000/mm3 \[SI units, \>/= 100 x 109/L\]
3. Adequate baseline liver function:
Total Bilirubin \< 3x ULN and
Without liver metastases:
AST (SGOT) \</= 2.5 x ULN ALT (SGPT) \</= 2.5 x ULN
With liver metastases:
AST (SGOT) \</= 5 x ULN ALT (SGPT) \</= 5 x ULN
4. Serum creatinine \</= 1.5 mg/dL \[SI units, 132 µmol/L\].
5. Performance status ECOG 0-1.
6. Male or female 18 - 75 years inclusive.
7. Minimum life expectancy of 3 months.
8. Written informed consent.
Exclusion Criteria
2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion
3. Immune-suppressive therapy \<4 weeks prior to inclusion
4. Chronic corticosteroid use except for asthma inhalers / topical use
5. Radiotherapy within 8 weeks of randomisation.
6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
7. Known diagnosis of HIV (AIDS), Hepatitis B, C.
8. Known history of or co-existing autoimmune disease.
9. Known CNS metastases.
10. Clinically significant serious disease or organ system disease not currently controlled on present therapy.
11. Pregnancy or lactation.
12. Women of childbearing potential not using reliable and adequate contraceptive methods\*
13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.
14. Unable for any other reason to comply with the protocol (treatment or assessments).
* Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
18 Years
75 Years
ALL
No
Sponsors
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ICON Clinical Research
INDUSTRY
ORION Clinical Services
INDUSTRY
CIRION Central Laboratory
UNKNOWN
Dorevitch
UNKNOWN
Syneos Health
OTHER
Pharmexa A/S
INDUSTRY
Responsible Party
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Pharmexa A/S
Principal Investigators
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Ask Aabenhus, MSc. (Pharm)
Role: STUDY_DIRECTOR
Pharmexa A/S
Locations
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University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States
The Center for Hematology-Oncology
Boca Raton, Florida, United States
Tampa General Hospital Usf Digestive Disorders Centre
Tampa, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Portneuf Cancer Center
Pocatello, Idaho, United States
Oncology Hematology Associates of Central Illinois, PC
Peoria, Illinois, United States
Hematology Oncology Specialists, Covington
Covington, Louisiana, United States
Berskhire Hematology Oncology PC
Pittsfield, Massachusetts, United States
Billings Clinic
Billings, Montana, United States
Carolinas Hematology Oncology Associates
Charlotte, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
Dallas, Texas, United States
Mary Crowley Medical Research Center, Worth St.
Dallas, Texas, United States
Oncology Consultants, PA
Houston, Texas, United States
St George Hospital, Department of Medical Oncology
Kogarah, New South Wales, Australia
Westmead Hospital, Dept. of Medical Oncology and Palliative Care
Westmead, New South Wales, Australia
The Townsville Hospital, Townsville Cancer Centre
Douglas, Queensland, Australia
Flinders Medical Centre, Medical Oncology - Clinical Trials
Bedford Park, South Australia, Australia
Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Royal Hobart Hospital, Centre for Clinical Research
Hobart, Tasmania, Australia
Box Hill Hospital, ECRU Oncology
Box Hill, Victoria, Australia
The Alfred Hospital, Medical Oncology Unit
Melbourne, Victoria, Australia
Fremantle Hospital, Haemtology Department
Fremantle, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Mount Medical Centre, Perth Oncology
Perth, Western Australia, Australia
Royal Perth Hospital, Department of Medical Oncology
Perth, Western Australia, Australia
Wesley Research Institute Limited
Auchenflower QLD, , Australia
Erasms University Hospital
Brussels, , Belgium
Hospital De Jolimont
Brussels, , Belgium
Ghent University Hospital, Digestive Oncology
Ghent, , Belgium
Oncology Department, Århus Hospital
Aarhus, , Denmark
Oncology Department, Herlev Hospital
Herlev, , Denmark
Odense Universitetshospital, Onkologisk afd. R
Odense, , Denmark
Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
Angers, , France
Oncologie Medicale, Clinic Pasteur
Évreux, , France
Hepatogastroenterology Dpt, University Hospital Center of Grenoble
Grenoble, , France
Service de Medicine Interne, CHRU de Lille
Lille, , France
Oncologie Midicale CHR Lorient
Lorient, , France
Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
Moreau, , France
Oncologie Médicale, Centre Cathrine de Siennes
Nantes, , France
Service de Cancerologie, Hospital Europeen Georges Pompidou
Paris, , France
Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
Saint-Brieuc, , France
Clinic Saint Vincent
Saint-Grégoire, , France
Oncology Trials Unit, Cork University Hospital
Cork, , Ireland
Cancer Clinical Trials Unit, Beaumont Hospital
Dublin, , Ireland
Cancer Research Unit, Mater Misericordlae University Hospital
Dublin, , Ireland
Department of Medical Oncology, Amnch
Dublin, , Ireland
Oncology Research Team, Mater Private University Hospital
Dublin, , Ireland
Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
Ancona, , Italy
Policlinico Universitario "Mater Domini", Unita Oncologia
Catanzaro, , Italy
Hospital "Careggi", Medical Oncology
Florence, , Italy
Azienda Ospedaliera, Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
Verona, , Italy
VU University Medical Center
Amsterdam, , Netherlands
Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
Bergen, , Norway
Sorlandet Hospital, Senter for Kreftbehandling
Kristiansand, , Norway
Ullevål Universitetssykehus, Gastrokirurgisk afd.
Oslo, , Norway
Department of Oncology, University Hospital of Northern-Norway
Tromsø, , Norway
Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
Bialystok, , Poland
W.S2.Z, Krolewiecka
Elblag, , Poland
Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
Krakow, , Poland
Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
Lodz, , Poland
Zaklad Opieki Zdrowotnej MSWiA
Olsztyn, , Poland
Centrum Onkologii, Wosewodzki Osrodek Onkologii
Opole, , Poland
Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
Wroclaw, , Poland
Hospital Clinic I Provincial De Barcelona
Barcelona, , Spain
Medical Oncology Department, General Hospital of Baza
Granada, , Spain
Medical Oncology Department, Virgen de Las Nieves Hospital
Granada, , Spain
Hospital Universitario Gregorio Marañón, Departamento de Oncología
Madrid, , Spain
Clínica Puerta de Hierro, Departamento de Oncología
Madrid, , Spain
Hospital Universitario La Paz, Departamento de Oncología
Madrid, , Spain
H. Monteprincipe
Madrid, , Spain
Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
Madrid, , Spain
HRU Carlos Haya, Medical Oncology Unit
Málaga, , Spain
Oncology Department, Clinic Universitary Hospital
Málaga, , Spain
Digestive Unit, Universitary Hospital Virgen de La Macarena
Seville, , Spain
Sahlgrenska Hospital, Head Division for Upper GI Surgery
Gothenburg, , Sweden
University Hospital, Department Of surgery and Gasterenterology
Lund, , Sweden
Department of Oncology, Malmö University Hospital
Malmo, , Sweden
Karolinska Institute / Hospital Solna, Department of Oncology
Stockholm, , Sweden
Department of Oncology, Karolinska Universitetssjukhuset
Stockholm, , Sweden
Countries
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Other Identifiers
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Eudract no. 2005-005014-21
Identifier Type: -
Identifier Source: secondary_id
PX115.1.1-302
Identifier Type: -
Identifier Source: org_study_id