NCT01757470

Brief Summary

Effectiveness of risk minimisation interventions for vandetanib in Canada

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

December 18, 2012

Last Update Submit

August 30, 2016

Conditions

Medullary Thyroid Cancer

Keywords

effectiveness of risk mitigation,knowledge and understanding survey,drug utilisation study,post marketing commitments

Outcome Measures

Primary Outcomes (13)

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

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

    2 months

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

    Discontinuation, interruption, continuous

    At baseline

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

    Discontinuation, interruption, continuous

    At 3 months

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

    Discontinuation, interruption, continuous

    At 6 months

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

    Discontinuation, interruption, continuous

    At 12 months

  • Drug Utilisation Study: Use of vandetanib - dosage at baseline

    At baseline

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

    At 3 months

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

    At 6 months

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

    At 12 months

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

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

    At baseline

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

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

    At 3 months

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

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

    At 6 months

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

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

    At 12 months

Secondary Outcomes (3)

  • Knowledge and Understanding Survey: Practice characteristics

    2 months

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

    2 months

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

    2 months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Convenience sample for patients and physicians

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 31, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

CA(1)