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Completed

NCT Number: NCT01757470

Vandetanib Risk Minimisation Effectiveness

Effectiveness of risk minimisation interventions for vandetanib in Canada

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Key information

Conditions

Medullary Thyroid Cancer Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

- N/A

Treatment and study plan

Primary outcomes

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

    Time frame: 2 months

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

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

    Time frame: At baseline

    Discontinuation, interruption, continuous

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

    Time frame: At 3 months

    Discontinuation, interruption, continuous

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

    Time frame: At 6 months

    Discontinuation, interruption, continuous

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

    Time frame: At 12 months

    Discontinuation, interruption, continuous

  6. Drug Utilisation Study: Use of vandetanib - dosage at baseline

    Time frame: At baseline

  7. Drug Utilisation Study: Use of vandetanib - dosage at 3 months

    Time frame: At 3 months

  8. Drug Utilisation Study: Use of vandetanib - dosage at 6 months

    Time frame: At 6 months

  9. Drug Utilisation Study: Use of vandetanib - dosage at 12 months

    Time frame: At 12 months

  10. Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline

    Time frame: At baseline

    Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs

  11. Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months

    Time frame: At 3 months

    Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs

  12. Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months

    Time frame: At 6 months

    Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs

  13. Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months

    Time frame: At 12 months

    Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs

Secondary outcomes

  1. Knowledge and Understanding Survey: Practice characteristics

    Time frame: 2 months

    Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date.

  2. Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training

    Time frame: 2 months

    Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board.

  3. Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib

    Time frame: 2 months

    Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2012
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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