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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
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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