Vandetanib Risk Minimisation Effectiveness

Genzyme

Status: Completed

Conditions: Medullary Thyroid Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01757470

D4200L00059

Details and patient eligibility

About

Effectiveness of risk minimisation interventions for vandetanib in Canada

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria: - N/A

Trial design

12 participants in 2 patient groups

Caprelsa Patient

Description:

All patients treated with Caprelsa in Canada and participating in the restricted distribution programme.

Caprelsa Prescriber

Description:

All physicians having prescribed at least one dose of Caprelsa and registered as a certified prescriber of Caprelsa in Canada.