Bevacizumab and Vasoconstriction
BVZ1
1 other identifier
interventional
10
1 country
1
Brief Summary
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. Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using plethysmography in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Jun 2009
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMay 18, 2010
June 1, 2009
5 months
June 25, 2009
May 17, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio
Infusion of bevacizumab during 6 minutes
Secondary Outcomes (1)
Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab
Infusion of bevacizumab during 6 minutes
Study Arms (1)
Bevacizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male 18-50 years old
- normal results of glucose, lipids and creatinine
- informed consent
You may not qualify if:
- History of abuse of drugs or alcohol
- History of malignant disease
- First degree relatives with a history of cancer before the age of 50
- First degree relatives with a history of premature cardiovascular disease
- Current use of medication
- Clinical evidence of cardiac of pulmonary disease
- Hypertension ( systolic\>140mmHg, diastolic \>90mmHg)
- Diabetes mellitus
- smoking
- a history of thombosis or a family history of recurrent thrombosis
- abnormality on ECG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Nijmegen Medical Centre
Nijmegen, 6500, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerard Rongen, MD PhD
UMCN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
May 18, 2010
Record last verified: 2009-06