Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446224
• Other study ID #: 114428
• Secondary ID: WEUKSTV4602
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: March 26, 2015
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Torsades de Pointes

Intervention

Drug:
• Pazopanib
Patients treated with pazopanib
• Other anti-VEGFs
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular ischemia	Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident	Over four years from approval of pazopanib	Yes
Secondary	Torsades de Pointes	Torsades de Pointes	Over four years from approval of pazopanib	Yes