Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01446224
First received: October 3, 2011
Last updated: April 3, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Torsades de Pointes


Estimated Enrollment: 1
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446224

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01446224     History of Changes
Other Study ID Numbers: 114428, WEUKSTV4602
Study First Received: October 3, 2011
Last Updated: April 3, 2014
Health Authority: United States: No Health Authority

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

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

ClinicalTrials.gov processed this record on October 22, 2014