NCT02185560

Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib

Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 453 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with Sorafenib within a certain period. The investigator should have made the choice of treatment (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this study. The enrollment period is of 9 months. The observation period for each patient starts when the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. Those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.

Conditions

• Thyroid Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Patients treated by Physician with Nexavar under approved local prescriptions

Timeline

• Start date: 2014-06-27
• Primary completion: 2020-02-27
• Completion: 2026-09-30
• First posted: 2014-07-09
• Last updated: 2026-04-14

Locations

1 site across 1 country: Japan