Medullary Thyroid CancerNCT01757470
Vandetanib Risk Minimisation Effectiveness
An observational study of Medullary Thyroid Cancer, run by Genzyme, a Sanofi Company at 1 site in Canada.
Trial summary
Effectiveness of risk minimisation interventions for vandetanib in Canada Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Cancer
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Feb 2014
- 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: Convenience sample for patients and physicians
Who may be able to join
- N/A (all patients taking Caprelsa and all prescribers will be contacted for participation).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada
Effectiveness of risk minimisation interventions for vandetanib in Canada
Read the 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.
- Conditions
- Medullary Thyroid Cancer
- Keywords
- effectiveness of risk mitigation,, knowledge and understanding survey,, drug utilisation study,, post marketing commitments
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib
QT prolongation/TdP Torsades, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response).
Measured: 2 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline
Discontinuation, interruption, continuous
Measured: At baseline
Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months
Discontinuation, interruption, continuous
Measured: At 3 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months
Discontinuation, interruption, continuous
Measured: At 6 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months
Discontinuation, interruption, continuous
Measured: At 12 months
Drug Utilisation Study: Use of vandetanib - dosage at baseline
Measured: At baseline
Drug Utilisation Study: Use of vandetanib - dosage at 3 months
Measured: At 3 months
Drug Utilisation Study: Use of vandetanib - dosage at 6 months
Measured: At 6 months
Drug Utilisation Study: Use of vandetanib - dosage at 12 months
Measured: At 12 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Measured: At baseline
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Measured: At 3 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Measured: At 6 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Measured: At 12 months
Secondary outcomes (3)
Knowledge and Understanding Survey: Practice characteristics
Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date.
Measured: 2 months
Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training
Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board.
Measured: 2 months
Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib
Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medullary Thyroid CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757470
- Sponsor's protocol ID
- D4200L00059
- Status last verified
- Aug 2016
- First submitted
- 18 Dec 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada
- ClinicalTrials.gov ID
- NCT01757470
- Acronym / sponsor ID
- D4200L00059
- Conditions
- Medullary Thyroid Cancer
- Keywords
- effectiveness of risk mitigation,, knowledge and understanding survey,, drug utilisation study,, post marketing commitments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Dec 2012 (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.
Effectiveness of risk minimisation interventions for vandetanib in Canada
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample for patients and physicians
Key inclusion criteria (1 listed)
- N/A (all patients taking Caprelsa and all prescribers will be contacted for participation).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline
Time frame: At baseline
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months
Time frame: At 3 months
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months
Time frame: At 6 months
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months
Time frame: At 12 months
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - dosage at baseline
Time frame: At baseline
Drug Utilisation Study: Use of vandetanib - dosage at 3 months
Time frame: At 3 months
Drug Utilisation Study: Use of vandetanib - dosage at 6 months
Time frame: At 6 months
Drug Utilisation Study: Use of vandetanib - dosage at 12 months
Time frame: 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
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
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
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
3 secondary outcomes
Knowledge and Understanding Survey: Practice characteristics
Time frame: 2 months
Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training
Time frame: 2 months
Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib
Time frame: 2 months
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 31 Aug 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medullary Thyroid Cancer, run by Genzyme, a Sanofi Company at 1 site in Canada.
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 1 inclusion and 0 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib (time frame: 2 months). The study lists 13 primary outcomes in all. 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 31 Aug 2016.