Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib
Conditions
Thyroid Carcinoma
Conditions: official terms
Carcinoma - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Sorafenib, Differentiated Thyroid Carcinoma,, Japan, Post Marketing Surveillance, Drug Use Investigation
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort
Intervention
Name: Sorafenib (Nexavar, BAY43-9006)
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)

Exclusion Criteria:

- Patients who have already received NEXAVAR treatment
Location
Many Locations, Japan
Status: Recruiting
Start Date
June 2014
Completion Date
June 2018
Sponsors
Bayer
Source
Bayer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page