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Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446224
First Posted: October 5, 2011
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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.


Condition Intervention
Carcinoma, Renal Cell Drug: Pazopanib Drug: Other anti-VEGFs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cardiovascular ischemia [ Time Frame: Over four years from approval of pazopanib ]
    Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident


Secondary Outcome Measures:
  • Torsades de Pointes [ Time Frame: Over four years from approval of pazopanib ]
    Torsades de Pointes


Enrollment: 1
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446224


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01446224     History of Changes
Other Study ID Numbers: 114428
WEUKSTV4602 ( Other Identifier: GSK )
First Submitted: October 3, 2011
First Posted: October 5, 2011
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by GlaxoSmithKline:
adverse events
pazopanib
Torsades des Pointes
renal cell carcinoma
anti-VEGF agents
observational data
cardiac ischemia

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Torsades de Pointes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Tachycardia, Ventricular
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents