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Active, Not Recruiting

NCT Number: NCT02185560

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Patients treated by Physician with Nexavar under approved local prescriptions

Primary outcomes

  1. Number of participants with Adverse drug reaction as a measure of safety and tolerability.

    Time frame: Up to 9 months

  2. Number of participants with Serious adverse events as a measure of safety and tolerability.

    Time frame: Up to 9 months

  3. Number of participants with Serious adverse drug reaction as a measure of safety and tolerability

    Time frame: Up to 9 months

Secondary outcomes

  1. 2-year survival

    Time frame: At 24 months

    Percentage of participants who survived 2 years from start of treatment

  2. Time of treatment failure (TTF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: JPMS-DTC

Important dates

Study start
2014
Primary completion
2020
Study completion
2026
First posted
Jul 9, 2014
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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