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Bevacizumab and Vasoconstriction (BVZ1)

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00929058
First received: June 25, 2009
Last updated: May 17, 2010
Last verified: June 2009
  Purpose

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 Intervention
Hypertension
Cancer
Drug: Bevacizumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Bevacizumab and Vasoconstriction

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Fore-arm vasomotor response to administered bevacizumab, expressed as percentage change in forearm blood flow ratio [ Time Frame: Infusion of bevacizumab during 6 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between VEGF concentrations in plasma and the vasoconstrictive response to bevacizumab [ Time Frame: Infusion of bevacizumab during 6 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab Drug: Bevacizumab
Intra-arterial infusion during 6 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929058

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

No publications provided

Responsible Party: Paul Smits, UMCN
ClinicalTrials.gov Identifier: NCT00929058     History of Changes
Other Study ID Numbers: BVZ1
Study First Received: June 25, 2009
Last Updated: May 17, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subject (CCMO)

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014