Vandetanib Risk Minimisation Effectiveness

Medullary Thyroid Cancer Clinical Trial

Official title:

Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757470
• Other study ID #: D4200L00059
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: August 30, 2016
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: August 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

Effectiveness of risk minimisation interventions for vandetanib in Canada

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria: - N/A

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Medullary Thyroid Cancer
• Thyroid Neoplasms

Locations

Country	Name	City	State
Canada	Research Site	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline	Discontinuation, interruption, continuous	At baseline	Yes
Primary	Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months	Discontinuation, interruption, continuous	At 3 months	Yes
Primary	Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months	Discontinuation, interruption, continuous	At 6 months	Yes
Primary	Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months	Discontinuation, interruption, continuous	At 12 months	Yes
Primary	Drug Utilisation Study: Use of vandetanib - dosage at baseline		At baseline	Yes
Primary	Drug Utilisation Study: Use of vandetanib - dosage at 3 months		At 3 months	Yes
Primary	Drug Utilisation Study: Use of vandetanib - dosage at 6 months		At 6 months	Yes
Primary	Drug Utilisation Study: Use of vandetanib - dosage at 12 months		At 12 months	Yes
Primary	Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline	Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs	At baseline	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No