Mechanisms of Anti-VEGF Induced Hypertension

NCT02156310 | Completed

• 1 other identifier: AAMFUSA001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: High blood pressure is a common complication observed in cancer patients prescribed anti-VEGF drugs. Increased blood pressure increases the risk of heart attacks and strokes, thus adversely affecting survival and quality of life in this patient group. However, little is known about the mechanisms leading to high blood pressure with anti-VEGF drugs. As a result, the management of anti-VEGF drug-induced hypertension is largely empirical. A better knowledge of effects of specific blood pressure lowering drugs, i.e. antihypertensives, on anti-VEGF drug-induced hypertension would optimize therapeutic management and reduce the risk associated with hypertension and proteinuria in patients with cancer. Methods: Datasets of two completed GSK clinical trials using the anti-VEGF drug pazopanib, i.e. VEG108844 and VEG105192, will be accessed to 1) determine the way blood pressure changes over time after commencing anti-VEGF treatment; 2) identify whether there are any relationships between pre-study and baseline blood pressure values, treatment with specific antihypertensive drugs, and changes in blood pressure after commencing anti-VEGF treatment; and 3) identify whether specific antihypertensive drugs and drug combinations, prescribed either before or after commencing anti-VEGF treatment, lead to a better blood pressure control and prevent proteinuria during anti-VEGF treatment. Specific statistical analyses will be conducted to assess and identify associations and will account for other patient's characteristics and repeated observations over time. The investigators plan to conduct this study over 6 months. Studies VEG108844 and VEG105192 have been selected as they investigate the same anti-VEGF drug, pazopanib, in a homogeneous group, i.e. patients with renal cancer. At the same time, inclusion of a placebo arm as well as a treatment arm with a different anti-VEGF drug, sunitimib, will allow initial comparisons across different groups. The results deriving from this study will provide important knowledge on 1) patterns of blood pressure changes with anti-VEGF drugs and 2) whether specific antihypertensive drugs or drug classes might be better than others in preventing and managing anti-VEGF induced hypertension and proteinuria.

Conditions

Renal Cancer

Outcome Measures

Primary Outcomes (1)

• Changes in systolic blood pressure with different anti-hypertensive drug classes in anti-VEGF induced hypertension

  6 months

Secondary Outcomes (1)

• Number of patients developing hypertension, i.e. >140/90 mmHg, with anti-VEGF drugs

  6 months

Other Outcomes (2)

• Number of patients developing proteinuria with anti-VEGF drugs

  6 months

• Survival of renal cancer patients on anti-VEGF drugs

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with renal cancer randomised to active treatment, active comparator or placebo in two finished randomised controlled trials

You may qualify if:

• Renal Cancer

You may not qualify if:

• Other terminal illness

Sponsors & Collaborators

• Arduino Mangoni: lead

Study Sites (1)

Department of Clinical Pharmacology

Adelaide, South Australia, 5042, Australia

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Arduino A Mangoni, MD, PhD

  Flinders University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Pharmacology

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 5, 2014
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

AU (1)