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

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ClinicalTrials.gov Identifier: NCT02109250
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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
Metastatic Medullary Thyroid Cancer Drug: Caprelsa

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Study Type : Observational [Patient Registry]
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 16 Months
Official Title: CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice
Study Start Date : April 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vandetanib

Group/Cohort 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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
It is planned to include all Belgian sites which have patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic MTC who have been prescribed vandetanib and fulfilling the criteria for reimbursement.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109250


Locations
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Belgium
Clinique du Sud Luxembourg
Arlon, Belgium, 6700
AZ Klina
Brasschaat, Belgium, 2930
Institut Jules Bordet
Brussels, Belgium, 1000
UZ Brussel
Brussels, Belgium, 1090
UCL St-Luc
Brussels, Belgium, 1200
UZ Gent
Gent, Belgium, 9000
AZ Delta
Roeselare, Belgium, 8800
CH de Wallonie
Tournai, Belgium, 7500
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Additional Information:
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02109250     History of Changes
Other Study ID Numbers: D4200R00001
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Medullary Thyroid Cancer (MTC) vandetanib caprelsa
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms