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Vandetanib Risk Minimisation Effectiveness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01757470
First received: December 18, 2012
Last updated: August 30, 2016
Last verified: August 2016
  Purpose
Effectiveness of risk minimisation interventions for vandetanib in Canada

Condition
Medullary Thyroid Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • 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).

  • Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline [ Time Frame: At baseline ]
    Discontinuation, interruption, continuous

  • Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months [ Time Frame: At 3 months ]
    Discontinuation, interruption, continuous

  • Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months [ Time Frame: At 6 months ]
    Discontinuation, interruption, continuous

  • Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months [ Time Frame: At 12 months ]
    Discontinuation, interruption, continuous

  • 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 ]
  • 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

  • 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

  • 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

  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.


Enrollment: 12
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Caprelsa Patient
All patients treated with Caprelsa in Canada and participating in the restricted distribution programme.
Caprelsa Prescriber
All physicians having prescribed at least one dose of Caprelsa and registered as a certified prescriber of Caprelsa in Canada.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Convenience sample for patients and physicians
Criteria

Inclusion Criteria:

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

Exclusion Criteria: - N/A

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757470

Locations
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01757470     History of Changes
Other Study ID Numbers: D4200L00059
Study First Received: December 18, 2012
Last Updated: August 30, 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
effectiveness of risk mitigation,
knowledge and understanding survey,
drug utilisation study,
post marketing commitments

Additional relevant MeSH terms:
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 21, 2017