Metastatic Medullary Thyroid CancerCaprelsaRegNCT02109250
CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice
An observational study of Metastatic Medullary Thyroid Cancer, run by Genzyme, a Sanofi Company at 8 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Medullary Thyroid Cancer
- What is being tested?
- Caprelsa
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 8 sitesBelgium
- Study dates
- Apr 2014to Jun 2015
- How long will I take part?
- 16 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
Clinique du Sud Luxembourg
Arlon, 6700
AZ Klina
Brasschaat, 2930
Institut Jules Bordet
Brussels, 1000
UZ Brussel
Brussels, 1090
UCL St-Luc
Brussels, 1200
UZ Gent
Ghent, 9000
AZ Delta
Roeselare, 8800
CH de Wallonie
Tournai, 7500
About this study
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.
- Conditions
- Metastatic Medullary Thyroid Cancer
- Being tested
- Caprelsa
- Keywords
- Medullary Thyroid Cancer (MTC) vandetanib caprelsa
- Medical subject headings
- Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaprelsaDrug
Caprelsa® 100 mg or 300 mg film-coated oral tablets. Each film-coated tablet contains 100 mg or 300 mg of vandetanib.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Caprelsa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Medullary Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
- Target duration
- 16 Months
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109250
- Sponsor's protocol ID
- D4200R00001
- Acronym
- CaprelsaReg
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice
- ClinicalTrials.gov ID
- NCT02109250
- Acronym / sponsor ID
- CaprelsaReg / D4200R00001
- Conditions
- Metastatic Medullary Thyroid Cancer
- Keywords
- Medullary Thyroid Cancer (MTC) vandetanib caprelsa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 16 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all Belgian patients treated with Caprelsa® (vandetanib) | – | Drug: CaprelsaIt 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaprelsaCaprelsa® 100 mg or 300 mg film-coated oral tablets. Each film-coated tablet contains 100 mg or 300 mg of vandetanib. | Drug | all Belgian patients treated with Caprelsa® (vandetanib) |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Medullary Thyroid Cancer, run by Genzyme, a Sanofi Company at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.