NCT02109250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

March 27, 2014

Last Update Submit

April 28, 2017

Conditions

Metastatic Medullary Thyroid Cancer

Keywords

Medullary Thyroid Cancer (MTC) vandetanib caprelsa

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

CaprelsaDRUG

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

all Belgian patients treated with Caprelsa® (vandetanib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinique du Sud Luxembourg

Arlon, 6700, Belgium

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UCL St-Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

CH de Wallonie

Tournai, 7500, Belgium

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

vandetanib

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
16 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 2, 2017

Record last verified: 2017-04

Locations

BE(8)