Bevacizumab and Vasoconstriction

Hypertension Clinical Trial

— BVZ1  

Official title:

Bevacizumab and Vasoconstriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929058
• Other study ID #: BVZ1
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: May 17, 2010
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: June 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subject (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male 18-50 years old

• normal results of glucose, lipids and creatinine

• informed consent

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer
• Hypertension

Intervention

Drug:
• Bevacizumab
Intra-arterial infusion during 6 minutes

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio		Infusion of bevacizumab during 6 minutes	No
Secondary	Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab		Infusion of bevacizumab during 6 minutes	No