Vandetanib Risk Minimisation Effectiveness

Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada

Effectiveness of risk minimisation interventions for vandetanib in Canada

Study Overview

• Status: Completed
• Conditions: Medullary Thyroid Cancer

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: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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).	2 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline	Discontinuation, interruption, continuous	At baseline
Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months	Discontinuation, interruption, continuous	At 3 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months	Discontinuation, interruption, continuous	At 6 months
Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months	Discontinuation, interruption, continuous	At 12 months
Drug Utilisation Study: Use of vandetanib - dosage at baseline		At baseline
Drug Utilisation Study: Use of vandetanib - dosage at 3 months		At 3 months
Drug Utilisation Study: Use of vandetanib - dosage at 6 months		At 6 months
Drug Utilisation Study: Use of vandetanib - dosage at 12 months		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	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	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	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	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	2 months

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: effectiveness of risk mitigation,; knowledge and understanding survey,; drug utilisation study,; post marketing commitments
• Other Study ID Numbers: D4200L00059