Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

This observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for Pazopanib use outside of the clinical trial setting. The aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients treated with marketed anti-VEGF agents [Pazopanib (VOTRIENT), Bevacizumab (AVASTIN), Sorafenib (NEXAVAR), and Sunitinib (SUTENT)].

Two databases will be utilized for this study: a large healthcare claims database in the U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and Torsades des Pointes.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Arterial Occlusive Diseases Arteriosclerosis Carcinoma Cardiovascular Diseases Coronary Artery Disease Coronary Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Myocardial Ischemia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The anti-VEGF cohorts will include patients with the following characteristics:

Adult patients (age ≥18 years)
Prescribed or administered an anti-VEGF agent: Pazopanib, Bevacizumab, Sorafenib or Sunitinib on or after approval date of Pazopanib
Diagnosed with renal cell cancer

Exclusion criteria

Patients with multiple primary cancer diagnoses

Treatment and study plan

Pazopanib

Drug

Patients treated with pazopanib

Other anti-VEGFs

Drug

Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib

Primary outcomes

Cardiovascular ischemia

Time frame: Over four years from approval of pazopanib

Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident

Secondary outcomes

Torsades de Pointes

Time frame: Over four years from approval of pazopanib

Torsades de Pointes

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Oct 5, 2011
Registry last updated: Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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