NCT01446224

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

October 3, 2011

Last Update Submit

March 26, 2015

Conditions

Carcinoma, Renal Cell

Keywords

adverse eventspazopanibTorsades des Pointesrenal cell carcinomaanti-VEGF agentsobservational datacardiac ischemia

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular ischemia

    Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident

    Over four years from approval of pazopanib

Secondary Outcomes (1)

  • Torsades de Pointes

    Over four years from approval of pazopanib

Study Arms (4)

Subjects who experience cardiac ischemia

Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident

Drug: PazopanibDrug: Other anti-VEGFs

Subjects who do not experience cardiac ischemia

Subjects who do not experience cardiac ischemia

Drug: PazopanibDrug: Other anti-VEGFs

Subjects who experience Torsades de Pointes

Subjects who experience Torsades de Pointes

Drug: PazopanibDrug: Other anti-VEGFs

Subjects who do not experience Torsades de Pointes

Subjects who do not experience Torsades de Pointes

Drug: PazopanibDrug: Other anti-VEGFs

Interventions

PazopanibDRUG

Patients treated with pazopanib

Subjects who do not experience Torsades de PointesSubjects who do not experience cardiac ischemiaSubjects who experience Torsades de PointesSubjects who experience cardiac ischemia
Other anti-VEGFsDRUG

Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib

Subjects who do not experience Torsades de PointesSubjects who do not experience cardiac ischemiaSubjects who experience Torsades de PointesSubjects who experience cardiac ischemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Patients with multiple primary cancer diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal CellCoronary Artery Disease

Interventions

pazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 5, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 27, 2015

Record last verified: 2015-03