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

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.

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Key information

Conditions

Metastatic Medullary Thyroid Cancer Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique du Sud Luxembourg, Arlon, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caprelsa

Drug

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

Primary outcomes

The primary objective of this registry is to describe the characteristics of patients who receive Caprelsa® and who are fulfilling the reimbursement criteria.

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Acronym: CaprelsaReg

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 9, 2014
Registry last updated: May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed