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

NCT02185560 | Active Not Recruiting

• 2 other identifiers: 17391NEXAVAR-TC-01
• Study Type: observational
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 2-year survival

  At 24 months

• Time of treatment failure (TTF)

  Up to 24 months

Study Arms (1)

BAY43-9006

NEXAVAR treatment group

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Patients treated by Physician with Nexavar under approved local prescriptions

BAY43-9006

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Sorafenib for Unresectable Differentiated Thyroid Carcinoma (DTC)

You may qualify if:

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

You may not qualify if:

• Patients who have already received NEXAVAR treatment

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 9, 2014
• Study Start: June 27, 2014
• Primary Completion: February 27, 2020
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

JP (1)