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

Active, not recruiting

• Conditions: Thyroid Carcinoma
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT02185560
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-27
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-09
• Primary Completion: 2020-02-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 453

Inclusion Criteria

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

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Exclusion Criteria

• Patients who have already received NEXAVAR treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY43-9006	Sorafenib (Nexavar, BAY43-9006)	NEXAVAR treatment group

Primary Outcome Measures

Name	Time	Method
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
Number of participants with Adverse drug reaction as a measure of safety and tolerability.	Up to 9 months

Secondary Outcome Measures

Name	Time	Method
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.