Last updated: 11/03/2018 16:38:38

Cardiovascular and Torsades de Pointes monitoring for Pazopanib

GSK study ID
114428
See study documents
Clinicaltrials.gov ID
NCT01446224
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Postmarketing cardiovascular ischemia and Torsades de Pointes monitoring for Pazopanib using observational databases
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Cardiovascular ischemia

Timeframe: Over four years from approval of pazopanib

Secondary outcomes:

Torsades de Pointes

Timeframe: Over four years from approval of pazopanib

Interventions:
Drug: Pazopanib
Drug: Other anti-VEGFs
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
December 2010 to December 2013
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • The anti-VEGF cohorts will include patients with the following characteristics:
  • Adult patients (age ≥18 years)
  • Patients with multiple primary cancer diagnoses
Inclusion and exclusion 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

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2013-02-12

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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