Trial Condition(s):
Thyroid carcinoma
Prospective, non-interventional, post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma and treated with Sorafenib (JPMS-DTC)
Bayer Identifier:
17391
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with Adverse drug reaction as a measure of safety and tolerability.Timeframe: Up to 9 months
- Number of participants with Serious adverse events as a measure of safety and tolerability.Timeframe: Up to 9 months
- Number of participants with Serious adverse drug reaction as a measure of safety and tolerabilityTimeframe: Up to 9 months
Secondary Outcome
- 2-year survivalPercentage of participants who survived 2 years from start of treatmentTimeframe: At 24 months
- 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.Timeframe: Up to 24 months
Additional Information
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