Bevacizumab and Vasoconstriction (BVZ1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929058
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : May 18, 2010
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Hypertension Cancer Drug: Bevacizumab Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Bevacizumab and Vasoconstriction
Study Start Date : June 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Bevacizumab Drug: Bevacizumab
Intra-arterial infusion during 6 minutes

Primary Outcome Measures :
  1. Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio [ Time Frame: Infusion of bevacizumab during 6 minutes ]

Secondary Outcome Measures :
  1. Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab [ Time Frame: Infusion of bevacizumab during 6 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00929058

Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500
Sponsors and Collaborators
Radboud University
Principal Investigator: Gerard Rongen, MD PhD UMCN

Responsible Party: Paul Smits, UMCN Identifier: NCT00929058     History of Changes
Other Study ID Numbers: BVZ1
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: June 2009

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents