Bevacizumab and Vasoconstriction (BVZ1)

May 17, 2010 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Drug: Bevacizumab
Intra-arterial infusion during 6 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio
Time Frame: Infusion of bevacizumab during 6 minutes
Infusion of bevacizumab during 6 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab
Time Frame: Infusion of bevacizumab during 6 minutes
Infusion of bevacizumab during 6 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Gerard Rongen, MD PhD, UMCN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2010

Last Update Submitted That Met QC Criteria

May 17, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVZ1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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