Carcinoma, Renal CellNCT01446224
Cardiovascular and Torsades de Pointes Monitoring for Pazopanib
An observational study of Carcinoma, Renal Cell, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Pazopanib and Other anti-VEGFs
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients with multiple primary cancer diagnoses
About this study
Official title: Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
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.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Pazopanib, Other anti-VEGFs
- Keywords
- adverse events, pazopanib, Torsades des Pointes, renal cell carcinoma, anti-VEGF agents, observational data, cardiac ischemia
- Medical subject headings
- Carcinoma, Renal Cell, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Patients treated with pazopanib
Other anti-VEGFsDrug
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
| Study group | Role | What they receive |
|---|---|---|
| Subjects who experience cardiac ischemia | Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident Receives: Drug: Pazopanib; Drug: Other anti-VEGFs | |
| Subjects who do not experience cardiac ischemia | Subjects who do not experience cardiac ischemia Receives: Drug: Pazopanib; Drug: Other anti-VEGFs | |
| Subjects who experience Torsades de Pointes | Subjects who experience Torsades de Pointes Receives: Drug: Pazopanib; Drug: Other anti-VEGFs | |
| Subjects who do not experience Torsades de Pointes | Subjects who do not experience Torsades de Pointes Receives: Drug: Pazopanib; Drug: Other anti-VEGFs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular ischemia
Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
Measured: Over four years from approval of pazopanib
Secondary outcomes (1)
Torsades de Pointes
Torsades de Pointes
Measured: Over four years from approval of pazopanib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446224
- Sponsor's protocol ID
- 114428
- Other IDs
- WEUKSTV4602
- Status last verified
- Mar 2015
- First submitted
- 3 Oct 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
- ClinicalTrials.gov ID
- NCT01446224
- Acronym / sponsor ID
- 114428
- Conditions
- Carcinoma, Renal Cell
- Keywords
- adverse events, pazopanib, Torsades des Pointes, renal cell carcinoma, anti-VEGF agents, observational data, cardiac ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects who experience cardiac ischemia | – | Drug: Pazopanib, Drug: Other anti-VEGFsSubjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident |
| Subjects who do not experience cardiac ischemia | – | Drug: Pazopanib, Drug: Other anti-VEGFsSubjects who do not experience cardiac ischemia |
| Subjects who experience Torsades de Pointes | – | Drug: Pazopanib, Drug: Other anti-VEGFsSubjects who experience Torsades de Pointes |
| Subjects who do not experience Torsades de Pointes | – | Drug: Pazopanib, Drug: Other anti-VEGFsSubjects who do not experience Torsades de Pointes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with multiple primary cancer diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibPatients treated with pazopanib | Drug | Subjects who do not experience Torsades de Pointes, Subjects who do not experience cardiac ischemia, Subjects who experience Torsades de Pointes, Subjects who experience cardiac ischemia |
| Other anti-VEGFsPatients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib | Drug | Subjects who do not experience Torsades de Pointes, Subjects who do not experience cardiac ischemia, Subjects who experience Torsades de Pointes, Subjects who experience cardiac ischemia |
Primary outcome
Cardiovascular ischemia
Time frame: Over four years from approval of pazopanib
Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
1 secondary outcome
Torsades de Pointes
Time frame: Over four years from approval of pazopanib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular ischemia (time frame: Over four years from approval of pazopanib). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.