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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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