Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects who experience cardiac ischemia

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

Pazopanib

Intervention Type DRUG

Patients treated with pazopanib

Other anti-VEGFs

Intervention Type DRUG

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

Subjects who do not experience cardiac ischemia

Pazopanib

Intervention Type DRUG

Patients treated with pazopanib

Other anti-VEGFs

Intervention Type DRUG

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

Subjects who experience Torsades de Pointes

Pazopanib

Intervention Type DRUG

Patients treated with pazopanib

Other anti-VEGFs

Intervention Type DRUG

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

Subjects who do not experience Torsades de Pointes

Pazopanib

Intervention Type DRUG

Patients treated with pazopanib

Other anti-VEGFs

Intervention Type DRUG

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

Interventions

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Pazopanib

Patients treated with pazopanib

Intervention Type DRUG

Other anti-VEGFs

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

Intervention Type DRUG

Eligibility Criteria

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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