Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01446224

Enrollment

Registered

2011-10-05

Start date

2010-12-31

Completion date

2013-12-31

Last updated

2015-03-27

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

Conditions

Carcinoma, Renal Cell

Keywords

adverse events, pazopanib, Torsades des Pointes, renal cell carcinoma, anti-VEGF agents, observational data, cardiac ischemia

Brief summary

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.

Interventions

DRUGPazopanib

Patients treated with pazopanib

DRUGOther anti-VEGFs

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiovascular ischemia	Over four years from approval of pazopanib	Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident

Secondary

Measure	Time frame	Description
Torsades de Pointes	Over four years from approval of pazopanib	Torsades de Pointes

Outcome results

None listed

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