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Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada


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Open (Enrolling)
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Medullary Thyroid Cancer

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Trial Information

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.


Inclusion Criteria:



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

Exclusion Criteria: - N/A

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib

Outcome Description:

QT prolongation/Torsades de Pointes, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response).

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Yola Moride, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Université de Montréal

Authority:

Canada: Health Canada

Study ID:

D4200L00059

NCT ID:

NCT01757470

Start Date:

July 2012

Completion Date:

December 2014

Related Keywords:

  • Medullary Thyroid Cancer
  • effectiveness of risk mitigation,
  • knowledge and understanding survey,
  • drug utilisation study,
  • post marketing committments
  • Thyroid Neoplasms

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