Angiogenesis Inhibitors and Hypertension: Clinical Aspects

This study has been completed.
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00511511
First received: August 3, 2007
Last updated: January 4, 2010
Last verified: July 2009
  Purpose

The aim of the study is to find simple clinical and laboratory parameters to predict the development of hypertension and to elucidate the mechanism of hypertension during treatment with the tyrosine kinase inhibitor Sunitinib.


Condition
Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Angiogenesis Inhibitors and Hypertension: Clinical Aspects

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Biospecimen Retention:   Samples Without DNA

Blood and urine samples


Estimated Enrollment: 80
Study Start Date: August 2007
Study Completion Date: December 2009
Detailed Description:

Inhibition of angiogenesis with antibodies against vascular endothelial growth factor (VEGF) and VEGF receptor antagonists has become an established treatment for cancer. An unanticipated side effect of angiogenesis inhibitors is the development of hypertension. The pathogenesis of this hypertension is unknown. Not all patients will develop hypertension. However, it is not known which patient will and which patient will not develop hypertension.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib

Criteria

Inclusion Criteria:

  • Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib.
  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: NCT00511511

Locations
Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: A. H. van den Meiracker, MD, PhD Erasmus Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00511511     History of Changes
Other Study ID Numbers: MEC-2007-155, EudraCT-number: 2007-002038-13
Study First Received: August 3, 2007
Last Updated: January 4, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
hypertension
angiogenesis inhibitors
tyrosine kinase inhibitor
Sunitinib

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

ClinicalTrials.gov processed this record on September 22, 2014