Vandetanib Risk Minimisation Effectiveness

This study has been completed.
Sponsor:
Collaborator:
Yolarx Consultants, Inc.
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01757470
First received: December 18, 2012
Last updated: June 13, 2014
Last verified: June 2014
  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 AstraZeneca:

Primary Outcome Measures:
  • Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Discontinuation, interruption, continuous

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

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

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

  • Drug Utilisation Study: Use of vandetanib - dosage at baseline [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  • Drug Utilisation Study: Use of vandetanib - dosage at 3 months [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]
  • Drug Utilisation Study: Use of vandetanib - dosage at 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
  • Drug Utilisation Study: Use of vandetanib - dosage at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
  • Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs


Secondary Outcome Measures:
  • Knowledge and Understanding Survey: Practice characteristics [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferences.


Estimated 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
Caplresa Patient
All patients treated with Caprelsa in Canada and participating in the restricted distribution programme.
Caplresa 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
Genders Eligible for Study:   Both
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
AstraZeneca
Yolarx Consultants, Inc.
Investigators
Principal Investigator: Yola Moride, PHD Université de Montréal
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01757470     History of Changes
Other Study ID Numbers: D4200L00059
Study First Received: December 18, 2012
Last Updated: June 13, 2014
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
effectiveness of risk mitigation,
knowledge and understanding survey,
drug utilisation study,
post marketing commitments

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Thyroid Diseases

ClinicalTrials.gov processed this record on October 23, 2014