Vandetanib Risk Minimisation Effectiveness

August 30, 2016 updated by: Genzyme, a Sanofi Company

Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada

Effectiveness of risk minimisation interventions for vandetanib in Canada

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

As part of the new drug approval process in Canada, AstraZeneca has committed to Health Canada to conduct a Drug Utilization Study among patients recently treated with CAPRELSA (vandetanib) and a Knowledge and Understanding Survey among the prescribing physicians to determine whether the product monograph, communication plan, and educational material developed by AstraZeneca Canada for vandetanib are adequate to provide knowledge about the potential risks associated with this product, and if other medications taken concomitantly with vandetanib are managed adequately.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Convenience sample for patients and physicians

Description

Inclusion Criteria:

- N/A (all patients taking Caprelsa and all prescribers will be contacted for participation).

Exclusion Criteria: - N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Caprelsa Patient
All patients treated with Caprelsa in Canada and participating in the restricted distribution programme.
Caprelsa Prescriber
All physicians having prescribed at least one dose of Caprelsa and registered as a certified prescriber of Caprelsa in Canada.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib
Time Frame: 2 months
QT prolongation/TdP Torsades, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response).
2 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline
Time Frame: At baseline
Discontinuation, interruption, continuous
At baseline
Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months
Time Frame: At 3 months
Discontinuation, interruption, continuous
At 3 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months
Time Frame: At 6 months
Discontinuation, interruption, continuous
At 6 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months
Time Frame: At 12 months
Discontinuation, interruption, continuous
At 12 months
Drug Utilisation Study: Use of vandetanib - dosage at baseline
Time Frame: At baseline
At baseline
Drug Utilisation Study: Use of vandetanib - dosage at 3 months
Time Frame: At 3 months
At 3 months
Drug Utilisation Study: Use of vandetanib - dosage at 6 months
Time Frame: At 6 months
At 6 months
Drug Utilisation Study: Use of vandetanib - dosage at 12 months
Time Frame: At 12 months
At 12 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline
Time Frame: At baseline
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
At baseline
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months
Time Frame: At 3 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
At 3 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months
Time Frame: At 6 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
At 6 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months
Time Frame: At 12 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
At 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge and Understanding Survey: Practice characteristics
Time Frame: 2 months
Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date.
2 months
Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training
Time Frame: 2 months
Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board.
2 months
Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib
Time Frame: 2 months
Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D4200L00059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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