Vandetanib Risk Minimisation Effectiveness

Genzyme, a Sanofi Company12 enrolled

Overview

Effectiveness of risk minimisation interventions for vandetanib in Canada

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

Conditions

Medullary Thyroid Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- N/A (all patients taking Caprelsa and all prescribers will be contacted for participation). Exclusion Criteria: - N/A

Locations (1)

Research Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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).

Time frame: 2 months

Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline

Discontinuation, interruption, continuous

Time frame: At baseline

Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months

Discontinuation, interruption, continuous

Time frame: At 3 months

Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months

Discontinuation, interruption, continuous

Time frame: At 6 months

Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months

Discontinuation, interruption, continuous

Time frame: At 12 months

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 months