Pharmacodynamic Effects of Anti-Vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies
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ClinicalTrials.gov Identifier: NCT00698659 |
Recruitment Status
:
Terminated
First Posted
: June 17, 2008
Last Update Posted
: December 11, 2013
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- To determine the effect of anti-vascular endothelial growth factor (VEGF) on endothelial function and on retinal microvasculature
- 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
- To characterize the effect of anti-VEGF therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung
Condition or disease |
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Hypertension Proteinuria |
Study Type : | Observational |
Time Perspective: | Prospective |
Official Title: | A Study of the Pharmacodynamic Effects of Anti-Vascular Endothelial Growth |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |
Group/Cohort |
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patients on anti-VEGF therapy
This study aims to assess the pharmacodynamic effects of anti-VEGF therapy. The following groups of patients will be approached: Those 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 All 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. 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. |
- Effect of VEGF on endothelial function and on retinal microvasculature and the pulmonary function of patients with malignancy (primary or secondary) involving the lung. [ Time Frame: until 4 weeks after end of treatment ]

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients who are receiving single agent anti-VEGF therapy
- Signed written informed consent.
- Patients with measurable pulmonary malignancy (primary or metastatic) as determined by RECIST will undergo assessment of pulmonary function.
- 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
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698659
Singapore | |
National University Hospital | |
Singapore, Singapore |
Principal Investigator: | Ross Andrew Soo, MBBS, MRCP | National University Hospital, Singapore |
Publications:
Responsible Party: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00698659 History of Changes |
Other Study ID Numbers: |
MC2/15/07 |
First Posted: | June 17, 2008 Key Record Dates |
Last Update Posted: | December 11, 2013 |
Last Verified: | April 2012 |
Additional relevant MeSH terms:
Proteinuria Urination Disorders Urologic Diseases Urological Manifestations |
Signs and Symptoms Endothelial Growth Factors Growth Substances Physiological Effects of Drugs |