CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice

NCT ID: NCT02109250

Last Updated: 2017-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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In this registry it is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib).

The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore real life data regarding demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be included.

Detailed Description

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Conditions

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Metastatic Medullary Thyroid Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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all Belgian patients treated with Caprelsa® (vandetanib)

It is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib).

Caprelsa

Intervention Type DRUG

Caprelsa® 100 mg or 300 mg film-coated oral tablets. Each film-coated tablet contains 100 mg or 300 mg of vandetanib.

Interventions

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Caprelsa

Caprelsa® 100 mg or 300 mg film-coated oral tablets. Each film-coated tablet contains 100 mg or 300 mg of vandetanib.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

The subject population that will be observed in this registry, must fulfil all of the following criteria:

1. Provision of subject Informed Consent
2. Patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic MTC
3. Patients who already received a prescription for vandetanib in accordance with the scientific leaflet and fulfilling the reimbursement criteria of vandetanib and who are currently treated or have been treated with vandetanib 100 mg or 300 mg tablets.

The prescription of the medicinal product is clearly separated from the decision to include the subject in the registry.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Clinique du Sud Luxembourg

Arlon, , Belgium

Site Status

AZ Klina

Brasschaat, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

UZ Brussel

Brussels, , Belgium

Site Status

UCL St-Luc

Brussels, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

AZ Delta

Roeselare, , Belgium

Site Status

CH de Wallonie

Tournai, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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D4200R00001

Identifier Type: -

Identifier Source: org_study_id

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