Study identification

PURI

https://redirect.ema.europa.eu/resource/46720

EU PAS number

EUPAS5094

Study ID

46720

Official title and acronym

International Observational, Study to Evaluate the Benefit/Risk of Vandetanib (Caprelsa™) 300 mg in RET Mutation Negative and RET Mutation Positive Patients with Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer (Caprelsa 104)

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

This was a prospective multinational, multicenter, noninterventional (observational) study of RET positive and RET negative patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC treated with Caprelsa (vandetanib). Because recruitment of RET negative patients was difficult, patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC treated or not with vandetanib and who were RET mutation negative were also retrospectively recruited at study sites. In addition, a total of 47 patients from the pivotal study D4200C00058 with reanalysed RET status (either positive or negative) were included. The decision to prescribe vandetanib was taken independently of the enrollment into this study and was in line with the respective (local) prescribing information. The study was observational, meaning that vandetanib treatment initiation should have never been delayed in order to meet any inclusion criteria of the study. Similarly, performing interventions on the patients that were specific for the study and would not have been carried out in the "real-life" setting was not permitted (eg, a biopsy). European countries where vandetanib is on the market (from 2012) participated in the study.

Study status

Finalised
Research institution and networks

Institutions

Sanofi
First published:
01/02/2024
Institution
Gustave Roussy
France
First published:
01/02/2024
Institution
Educational InstitutionHospital/Clinic/Other health care facility
- Bordet - Brussel, Belgium
- Universitair Ziekenhuis - Brussel, Belgium
- Centre Léon Berard - Lyon, France
- Institut Bergonié - Bordeaux, France
- Gemeinschaftspraxis Endokrinologie - Heidelberg, Germany
- Klinik für Nuklearmedizin - Augsburg, Germany
- Universitätsklinikum Essen - Germany
- Klinikum der Universität München - Germany
- Universitair Medisch Centrum Groningen, Netherlands
- Hospital Ramón y Cajal - Madrid, Spain
- AO Niguarda - Milan, Italy
- Policlinico Mangiagalli - Milan, Italy
- Istituto Oncologico Europeo - Milan, Italy
- A.O.U. Pisana - Ospedale Cisanello - Pisa, Italy
- Weston Park Hospital - Sheffield, United Kingdom
- St Bartholomews Hospital - London, United Kingdom
- St Thomas' Hospital - London, United Kingdom

Contact details

Trial Transparency Team

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Study protocol
Initial protocol

Approved Edition n 4 5 February 2013 NIS Protocol

English (323.39 KB - PDF)View document
Updated protocol

rdct-obs14778-amended-protocol02-approved-PDFA

English (1001.8 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 2 (specific obligation of marketing authorisation)