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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02109250

Collaborator

(none)

Enrollment

Locations

Duration (Months)

1.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Medullary Thyroid Cancer	Drug: Caprelsa

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

10 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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).	Drug: Caprelsa Caprelsa® 100 mg or 300 mg film-coated oral tablets. Each film-coated tablet contains 100 mg or 300 mg of vandetanib.

Arm

Intervention/Treatment

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).

Drug: Caprelsa

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

Outcome Measures

Primary Outcome Measures

The primary objective of this registry is to describe the characteristics of patients who receive Caprelsa® and who are fulfilling the reimbursement criteria. [Up to 16 months]
In this registry the following real life data will be collected: demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with vandetanib and time of progression or death (if applicable).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

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

Provision of subject Informed Consent
Patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic MTC
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.

Exclusion criteria Not applicable since patients participating in another study can take part in this registry.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique du Sud Luxembourg	Arlon	Belgium	6700
2	AZ Klina	Brasschaat	Belgium	2930
3	Institut Jules Bordet	Brussels	Belgium	1000
4	UZ Brussel	Brussels	Belgium	1090
5	UCL St-Luc	Brussels	Belgium	1200
6	UZ Gent	Gent	Belgium	9000
7	AZ Delta	Roeselare	Belgium	8800
8	CH de Wallonie	Tournai	Belgium	7500

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

CSR Synopsis

Publications

None provided.

Responsible Party:

Genzyme, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT02109250

Other Study ID Numbers:

D4200R00001

First Posted:

Apr 9, 2014

Last Update Posted:

May 2, 2017

Last Verified:

Apr 1, 2017

Keywords provided by Genzyme, a Sanofi Company

Medullary Thyroid Cancer (MTC) vandetanib caprelsa

Additional relevant MeSH terms:

Thyroid Neoplasms

Study Results

No Results Posted as of May 2, 2017