Vandetanib Risk Minimisation Effectiveness

Completed

• Conditions: Medullary Thyroid Cancer

• Registration Number: NCT01757470
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-31
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline	At baseline	Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months	At 3 months	Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months	At 12 months	Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - dosage at 6 months	At 6 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline	At baseline	Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months	At 12 months	Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib	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 - dosage at baseline	At baseline
Drug Utilisation Study: Use of vandetanib - dosage at 12 months	At 12 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months	At 3 months	Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months	At 6 months	Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - dosage at 3 months	At 3 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months	At 6 months	Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs

Secondary Outcome Measures

Name	Time	Method
Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training	2 months	Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board.
Knowledge and Understanding Survey: Practice characteristics	2 months	Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date.
Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib	2 months	Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences.

Trial Locations

Locations (1)

Research Site; 🇨🇦 Montreal, Quebec, Canada