Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

March 26, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study cohorts will be created in two healthcare databases to follow the outcomes of interest in (i) Pazopanib users, and (ii) users of other marketed anti-VEGF drugs (Bevacizumab, Sorafenib, Sunitinib).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who experience cardiac ischemia
Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
Drug: Pazopanib
Patients treated with pazopanib
Drug: Other anti-VEGFs
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
Subjects who do not experience cardiac ischemia
Drug: Pazopanib
Patients treated with pazopanib
Drug: Other anti-VEGFs
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
Subjects who experience Torsades de Pointes
Drug: Pazopanib
Patients treated with pazopanib
Drug: Other anti-VEGFs
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
Subjects who do not experience Torsades de Pointes
Drug: Pazopanib
Patients treated with pazopanib
Drug: Other anti-VEGFs
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Torsades de Pointes
Time Frame: Over four years from approval of pazopanib
Torsades de Pointes
Over four years from approval of pazopanib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 3, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114428
  • WEUKSTV4602 (Other Identifier: GSK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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