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

Thyroid Carcinoma Clinical Trial

— JPMS-DTC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02185560
• Other study ID #: 17391
• Secondary ID: NEXAVAR-TC-01
• Status: Active, not recruiting
• Start date: June 27, 2014
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 453
• Est. completion date: June 30, 2024
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Patients treated by Physician with Nexavar under approved local prescriptions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse drug reaction as a measure of safety and tolerability.		Up to 9 months
Primary	Number of participants with Serious adverse events as a measure of safety and tolerability.		Up to 9 months
Primary	Number of participants with Serious adverse drug reaction as a measure of safety and tolerability		Up to 9 months
Secondary	2-year survival	Percentage of participants who survived 2 years from start of treatment	At 24 months
Secondary	Time of treatment failure (TTF)	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.	Up to 24 months

External Links

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