Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-09 @ 5:14 AM
Study NCT ID:
NCT00698659
Status:
TERMINATED
Last Update Posted:
2013-12-11
First Post:
2008-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Effects of Anti-Vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2008-06-15', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of VEGF on endothelial function and on retinal microvasculature and the pulmonary function of patients with malignancy (primary or secondary) involving the lung.', 'timeFrame': 'until 4 weeks after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Proteinuria']}, 'referencesModule': {'references': [{'pmid': '11104784', 'type': 'BACKGROUND', 'citation': 'Kasahara Y, Tuder RM, Taraseviciene-Stewart L, Le Cras TD, Abman S, Hirth PK, Waltenberger J, Voelkel NF. Inhibition of VEGF receptors causes lung cell apoptosis and emphysema. J Clin Invest. 2000 Dec;106(11):1311-9. doi: 10.1172/JCI10259.'}, {'pmid': '16446323', 'type': 'BACKGROUND', 'citation': "Veronese ML, Mosenkis A, Flaherty KT, Gallagher M, Stevenson JP, Townsend RR, O'Dwyer PJ. Mechanisms of hypertension associated with BAY 43-9006. J Clin Oncol. 2006 Mar 20;24(9):1363-9. doi: 10.1200/JCO.2005.02.0503. Epub 2006 Jan 30."}]}, 'descriptionModule': {'briefSummary': '1. To determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function and on retinal microvasculature\n2. To determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria in patients treated with anti-VEGF agents\n3. To characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung', 'detailedDescription': 'The well-established role of vascular endothelial growth factor (VEGF) in carcinogenesis and tumor angiogenesis has led to the development of agents that target this pathway. Anti-VEGF agents the VEGF monoclonal antibody bevacizumab, and the small molecule VEGF receptor tyrosine kinase inhibitors. Angiogenic factors play a key role in the maintenance of lung integrity and normal endothelial function. Endothelial dysfunction has been implicated in hypertension, proteinuria and retinopathy. One of the major issues of anti-VEGF agents is its long-term toxicity especially taking into account the lack of adequate knowledge in this area and the possibility of prolonged periods of therapy in non-progressing patients. Hypertension and proteinuria are commonly seen in patients treated with anti-VEGF agents. In addition, we have also observed in a relatively high frequency of pulmonary air-filled lesions in patients with malignancy in the lung treated with an anti-VEGF agent. Objectives of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function 2) determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria 3) characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung in patients treated with anti-VEGF agents. Pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function, assess the effects of anti-VEGF therapy by assessing brachial artery reactivity, retinal vasculature and pulmonary function in a subset of patients receiving anti-VEGF therapy. The development of markers of endothelial dysfunction may result in the early identification of patients who are non-responders or develop toxicity from anti-VEGF treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those who are starting on anti-VEGF therapy (such as but not limited to bevacizumab, sunitinib, and sorafenib) as part of routine clinical management', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are receiving single agent anti-VEGF therapy\n* Signed written informed consent.\n* Patients with measurable pulmonary malignancy (primary or metastatic) as determined by RECIST will undergo assessment of pulmonary function.\n* Patients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00698659', 'briefTitle': 'Pharmacodynamic Effects of Anti-Vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'A Study of the Pharmacodynamic Effects of Anti-Vascular Endothelial Growth', 'orgStudyIdInfo': {'id': 'MC2/15/07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients on anti-VEGF therapy', 'description': 'This study aims to assess the pharmacodynamic effects of anti-VEGF therapy. The following groups of patients will be approached:\n\nThose who are starting on anti-VEGF therapy (such as but not limited to bevacizumab, sunitinib, and sorafenib) as part of routine clinical management or on clinical studies\n\nAll patients must be aged aged ≥ 21 years All patients must have a signed written informed consent prior to study enrollment. A separate consent will be obtained from patients already involved in a clinical study using anti-VEGF treatment.\n\nPatients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Ross Andrew Soo, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}