Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT00929058
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2009-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bevacizumab and Vasoconstriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-17', 'studyFirstSubmitDate': '2009-06-25', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio', 'timeFrame': 'Infusion of bevacizumab during 6 minutes'}], 'secondaryOutcomes': [{'measure': 'Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab', 'timeFrame': 'Infusion of bevacizumab during 6 minutes'}]}, 'conditionsModule': {'conditions': ['Hypertension', 'Cancer']}, 'descriptionModule': {'briefSummary': 'Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most common side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear.\n\nObjective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male 18-50 years old\n* normal results of glucose, lipids and creatinine\n* informed consent\n\nExclusion Criteria:\n\n* History of abuse of drugs or alcohol\n* History of malignant disease\n* First degree relatives with a history of cancer before the age of 50\n* First degree relatives with a history of premature cardiovascular disease\n* Current use of medication\n* Clinical evidence of cardiac of pulmonary disease\n* Hypertension ( systolic\\>140mmHg, diastolic \\>90mmHg)\n* Diabetes mellitus\n* smoking\n* a history of thombosis or a family history of recurrent thrombosis\n* abnormality on ECG'}, 'identificationModule': {'nctId': 'NCT00929058', 'acronym': 'BVZ1', 'briefTitle': 'Bevacizumab and Vasoconstriction', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Bevacizumab and Vasoconstriction', 'orgStudyIdInfo': {'id': 'BVZ1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Intra-arterial infusion during 6 minutes', 'armGroupLabels': ['Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Gerard Rongen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMCN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paul Smits', 'oldOrganization': 'UMCN'}}}}