Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Other anti-VEGFs; Drug: Pazopanib

Study type: Observational

Funder types: Industry

Identifiers

NCT01446224

114428

WEUKSTV4602 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

1 participants in 4 patient groups

Subjects who experience cardiac ischemia

Description:

Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident

Treatment:

Drug: Other anti-VEGFs

Drug: Pazopanib

Subjects who do not experience cardiac ischemia

Description:

Subjects who do not experience cardiac ischemia

Treatment:

Drug: Other anti-VEGFs

Drug: Pazopanib

Subjects who experience Torsades de Pointes

Description:

Subjects who experience Torsades de Pointes

Treatment:

Drug: Other anti-VEGFs

Drug: Pazopanib

Subjects who do not experience Torsades de Pointes

Description:

Subjects who do not experience Torsades de Pointes

Treatment:

Drug: Other anti-VEGFs

Drug: Pazopanib