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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02185560

Acronym

JPMS-DTC

Enrollment

453

Registered

2014-07-09

Start date

2014-06-27

Completion date

2026-09-30

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Carcinoma

Keywords

Sorafenib, Differentiated Thyroid Carcinoma,, Japan, Post Marketing Surveillance, Drug Use Investigation

Brief 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.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

Patients treated by Physician with Nexavar under approved local prescriptions

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with Adverse drug reaction as a measure of safety and tolerability.	Up to 9 months
Number of participants with Serious adverse events as a measure of safety and tolerability.	Up to 9 months
Number of participants with Serious adverse drug reaction as a measure of safety and tolerability	Up to 9 months

Secondary

Measure	Time frame	Description
2-year survival	At 24 months	Percentage of participants who survived 2 years from start of treatment
Time of treatment failure (TTF)	Up to 24 months	Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death.

Countries

Japan

Contacts

STUDY_DIRECTORBayer Study Director

Bayer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026