Trial Condition(s):

Thyroid carcinoma

Prospective, non-interventional, post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma and treated with Sorafenib (JPMS-DTC)

Bayer Identifier:

17391

ClinicalTrials.gov Identifier:

NCT02185560

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
453
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Active, not recruiting
 

Trial Design