Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT00358566
Status:
TERMINATED
Last Update Posted:
2008-05-19
First Post:
2006-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514987', 'term': 'GV1001 peptide'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'whyStopped': 'Preliminary data showed no survival benefit in the GV1001 group compared to the gemcitabine group.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-16', 'studyFirstSubmitDate': '2006-07-14', 'studyFirstSubmitQcDate': '2006-07-31', 'lastUpdatePostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival time', 'timeFrame': '12 month'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Time of progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced', 'Unresesctable', 'Adenocarcinoma', 'Pancreatic cancer'], 'conditions': ['Advanced Unresectable Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.', 'detailedDescription': 'The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.\n2. Adequate hematological parameters:\n\n 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\\]\n3. Adequate baseline liver function:\n\n Total Bilirubin \\< 3x ULN and\n\n Without liver metastases:\n\n AST (SGOT) \\</= 2.5 x ULN ALT (SGPT) \\</= 2.5 x ULN\n\n With liver metastases:\n\n AST (SGOT) \\</= 5 x ULN ALT (SGPT) \\</= 5 x ULN\n4. Serum creatinine \\</= 1.5 mg/dL \\[SI units, 132 µmol/L\\].\n5. Performance status ECOG 0-1.\n6. Male or female 18 - 75 years inclusive.\n7. Minimum life expectancy of 3 months.\n8. Written informed consent.\n\nExclusion Criteria:\n\n1. Treatment with chemotherapy for pancreatic cancer.\n2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion\n3. Immune-suppressive therapy \\<4 weeks prior to inclusion\n4. Chronic corticosteroid use except for asthma inhalers / topical use\n5. Radiotherapy within 8 weeks of randomisation.\n6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.\n7. Known diagnosis of HIV (AIDS), Hepatitis B, C.\n8. Known history of or co-existing autoimmune disease.\n9. Known CNS metastases.\n10. Clinically significant serious disease or organ system disease not currently controlled on present therapy.\n11. Pregnancy or lactation.\n12. Women of childbearing potential not using reliable and adequate contraceptive methods\\*\n13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.\n14. Unable for any other reason to comply with the protocol (treatment or assessments).\n\n * 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.'}, 'identificationModule': {'nctId': 'NCT00358566', 'briefTitle': 'GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmexa A/S'}, 'officialTitle': '"Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.', 'orgStudyIdInfo': {'id': 'PX115.1.1-302'}, 'secondaryIdInfos': [{'id': 'Eudract no. 2005-005014-21'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine', 'description': 'Gemcitabine alone treatment.', 'interventionNames': ['Drug: Gemcitabine (Chemotherapy)']}, {'type': 'EXPERIMENTAL', 'label': 'GV1001', 'description': 'GV1001 in sequential combination with Gemcitabine', 'interventionNames': ['Biological: GV1001']}], 'interventions': [{'name': 'GV1001', 'type': 'BIOLOGICAL', 'otherNames': ['INN-name: Termotide'], 'description': '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.', 'armGroupLabels': ['GV1001']}, {'name': 'Gemcitabine (Chemotherapy)', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': '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.', 'armGroupLabels': ['Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Center', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic Torrey Pines', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Hematology-Oncology', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital Usf Digestive Disorders Centre', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Cancer Institute', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '83204', 'city': 'Pocatello', 'state': 'Idaho', 'country': 'United States', 'facility': 'Portneuf Cancer Center', 'geoPoint': {'lat': 42.8713, 'lon': -112.44553}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Hematology Associates of Central Illinois, PC', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Hematology Oncology Specialists, Covington', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '01201', 'city': 'Pittsfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Berskhire Hematology Oncology PC', 'geoPoint': {'lat': 42.45008, 'lon': -73.24538}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Clinic', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Hematology Oncology Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Toledo Community Hospital Oncology Program', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Regional Cancer Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75249', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center, Worth St.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oncology Consultants, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'NSW 2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St George Hospital, Department of Medical Oncology', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': 'NSW 2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital, Dept. of Medical Oncology and Palliative Care', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': 'QLD 4814', 'city': 'Douglas', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Townsville Hospital, Townsville Cancer Centre', 'geoPoint': {'lat': -19.32394, 'lon': 146.75234}}, {'zip': 'SA 5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre, Medical Oncology - Clinical Trials', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': 'TAS 7000', 'city': 'Hobart', 'state': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital, Centre for Clinical Research', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': 'VIC 3128', 'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Box Hill Hospital, ECRU Oncology', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': 'VIC 3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital, Medical Oncology Unit', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'WA 6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Fremantle Hospital, Haemtology Department', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'WA 6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Mount Medical Centre, Perth Oncology', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'WA 6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital, Department of Medical Oncology', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Auchenflower QLD', 'country': 'Australia', 'facility': 'Wesley Research Institute Limited'}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasms University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '7100', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hospital De Jolimont', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital, Digestive Oncology', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Oncology Department, Århus Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Herlev', 'country': 'Denmark', 'facility': 'Oncology Department, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Universitetshospital, Onkologisk afd. R', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '27000', 'city': 'Évreux', 'country': 'France', 'facility': 'Oncologie Medicale, Clinic Pasteur', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Hepatogastroenterology Dpt, University Hospital Center of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Service de Medicine Interne, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '56100', 'city': 'Lorient', 'country': 'France', 'facility': 'Oncologie Midicale CHR Lorient', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '85925', 'city': 'Moreau', 'country': 'France', 'facility': 'Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale', 'geoPoint': {'lat': 45.57269, 'lon': 4.52326}}, {'zip': '44200', 'city': 'Nantes', 'country': 'France', 'facility': 'Oncologie Médicale, Centre Cathrine de Siennes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Cancerologie, Hospital Europeen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Medical Oncology Dpt, Armoricaine Private Hospital of Radiology', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '35760', 'city': 'Saint-Grégoire', 'country': 'France', 'facility': 'Clinic Saint Vincent', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Oncology Trials Unit, Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Cancer Clinical Trials Unit, Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Cancer Research Unit, Mater Misericordlae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Department of Medical Oncology, Amnch', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Oncology Research Team, Mater Private University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '60100', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Policlinico Universitario "Mater Domini", Unita Oncologia', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'Hospital "Careggi", Medical Oncology', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera, Arcispedale S. Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '4604', 'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Sorlandet Hospital, Senter for Kreftbehandling', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}, {'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevål Universitetssykehus, Gastrokirurgisk afd.', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'Department of Oncology, University Hospital of Northern-Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '15-027', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'W.S2.Z, Krolewiecka', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '31-826', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '10-228', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Zaklad Opieki Zdrowotnej MSWiA', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '45-060', 'city': 'Opole', 'country': 'Poland', 'facility': 'Centrum Onkologii, Wosewodzki Osrodek Onkologii', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '53-143', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I Provincial De Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Medical Oncology Department, General Hospital of Baza', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Medical Oncology Department, Virgen de Las Nieves Hospital', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Gregorio Marañón, Departamento de Oncología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clínica Puerta de Hierro, Departamento de Oncología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz, Departamento de Oncología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28660', 'city': 'Madrid', 'country': 'Spain', 'facility': 'H. Monteprincipe', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28922', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundaciόn Hospital de Alcorcόn, Unidad de Oncología', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'HRU Carlos Haya, Medical Oncology Unit', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Oncology Department, Clinic Universitary Hospital', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Digestive Unit, Universitary Hospital Virgen de La Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Hospital, Head Division for Upper GI Surgery', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'University Hospital, Department Of surgery and Gasterenterology', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'Department of Oncology, Malmö University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute / Hospital Solna, Department of Oncology', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'SE- 171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Oncology, Karolinska Universitetssjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Ask Aabenhus, MSc. (Pharm)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pharmexa A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmexa A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON Clinical Research', 'class': 'INDUSTRY'}, {'name': 'ORION Clinical Services', 'class': 'INDUSTRY'}, {'name': 'CIRION Central Laboratory', 'class': 'UNKNOWN'}, {'name': 'Dorevitch', 'class': 'UNKNOWN'}, {'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ask Aabenhus, Clinical Trial Manager', 'oldOrganization': 'Pharmexa A/S'}}}}