Bevacizumab and Endothelium Dependent Vasodilation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125943

Enrollment

Registered

2010-05-19

Start date

2010-06-30

Completion date

2011-11-30

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Cancer, Endothelial Dysfunction

Brief summary

The introduction of angiogenesis inhibitors has remarkably improved treatment of patients with several types of cancer. One of the most reported side effects of angiogenesis inhibitors is hypertension. In patients treated with bevacizumab, a monoclonal antibody against vascular endothelial growth factor, hypertension had an overall incidence up to 32%. The increase in blood pressure occurs early in treatment. The etiology of hypertension caused by treatment with angiogenesis inhibitors is unclear. Understanding the pathogenesis of this side effect is essential for optimal treatment with this class of drugs. The primary objective is to explore the effect of bevacizumab infusion on endothelium-dependent vasodilation of forearm resistance arteries.

Interventions

DRUGAcetylcholine

Intra-arterial infusion

DRUGNitroprusside

Intra arterial infusion

DRUGBevacizumab

Intra arterial infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Age 18-50 years old 2. Male 3. Results of serum glucose, lipids and creatinine should be within the laboratory's reference ranges. 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion criteria

1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. 2. History of or current abuse of drugs, alcohol or solvents. 3. History of malignant disease. 4. First degree relatives with a history of cancer before the age of 50 5. First degree relatives with a history of premature cardiovascular disease before the age of 50 6. Current use of medication. 7. Clinical evidence of cardiac or pulmonary disease 8. Hypertension ( systole \>140mmHG, diastole \>90mmHg) 9. Diabetes mellitus 10. Smoking 11. Any clinically relevant abnormality on ECG. 12. A history of thrombosis or first degree family members with a history of recurrent thrombosis 13. Inability to understand the nature and extent of the trial and the procedures required. 14. Previous participation in a study with bevacizumab

Design outcomes

Primary

Measure	Time frame	Description
Vasomotor response assessed by venous occlusion strain gauge plethysmography	15 minutes	Response to infusion of bevacizumab and/or acetylcholin or nitroprusside

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026