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

Metastatic Medullary Thyroid Cancer Clinical Trial

— CaprelsaReg  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109250
• Other study ID #: D4200R00001
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 28, 2017
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Metastatic Medullary Thyroid Cancer
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Clinique du Sud Luxembourg	Arlon
Belgium	AZ Klina	Brasschaat
Belgium	Institut Jules Bordet	Brussels
Belgium	UCL St-Luc	Brussels
Belgium	UZ Brussel	Brussels
Belgium	UZ Gent	Gent
Belgium	AZ Delta	Roeselare
Belgium	CH de Wallonie	Tournai

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this registry is to describe the characteristics of patients who receive Caprelsa® and who are fulfilling the reimbursement criteria.	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).	Up to 16 months

External Links

•   CSR Synopsis