Thyroid CarcinomaJPMS-DTCNCT02185560
Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib
An observational study of Thyroid Carcinoma, run by Bayer at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Carcinoma
- What is being tested?
- Sorafenib (Nexavar, BAY43-9006)
- How many people
- 453 participants
- Where
- 1 siteJapan
- Study dates
- 27 Jun 2014to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with Sorafenib for Unresectable Differentiated Thyroid Carcinoma (DTC)
Who may be able to join
- Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)
Who cannot join
- Patients who have already received NEXAVAR treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
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
- Being tested
- Sorafenib (Nexavar, BAY43-9006)
- Keywords
- Sorafenib, Differentiated Thyroid Carcinoma,, Japan, Post Marketing Surveillance, Drug Use Investigation
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (Nexavar, BAY43-9006)Drug
Patients treated by Physician with Nexavar under approved local prescriptions
| Study group | Role | What they receive |
|---|---|---|
| BAY43-9006 | NEXAVAR treatment group Receives: Drug: Sorafenib (Nexavar, BAY43-9006) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse drug reaction as a measure of safety and tolerability.
Measured: Up to 9 months
Number of participants with Serious adverse events as a measure of safety and tolerability.
Measured: Up to 9 months
Number of participants with Serious adverse drug reaction as a measure of safety and tolerability
Measured: Up to 9 months
Secondary outcomes (2)
2-year survival
Percentage of participants who survived 2 years from start of treatment
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start27 Jun 2014
- Primary completion27 Feb 2020
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185560
- Sponsor's protocol ID
- 17391
- Other IDs
- NEXAVAR-TC-01
- Acronym
- JPMS-DTC
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2014
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
- ClinicalTrials.gov ID
- NCT02185560
- Acronym / sponsor ID
- JPMS-DTC / 17391
- Conditions
- Thyroid Carcinoma
- Keywords
- Sorafenib, Differentiated Thyroid Carcinoma,, Japan, Post Marketing Surveillance, Drug Use Investigation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 453 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY43-9006 | – | Drug: Sorafenib (Nexavar, BAY43-9006)NEXAVAR treatment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with Sorafenib for Unresectable Differentiated Thyroid Carcinoma (DTC)
Key inclusion criteria (1 listed)
- Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)
Key exclusion criteria (1 listed)
- Patients who have already received NEXAVAR treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006)Patients treated by Physician with Nexavar under approved local prescriptions | Drug | BAY43-9006 |
Primary outcome
Number of participants with Adverse drug reaction as a measure of safety and tolerability.
Time frame: Up to 9 months
Number of participants with Serious adverse events as a measure of safety and tolerability.
Time frame: Up to 9 months
Number of participants with Serious adverse drug reaction as a measure of safety and tolerability
Time frame: Up to 9 months
2 secondary outcomes
2-year survival
Time frame: At 24 months
Time of treatment failure (TTF)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Carcinoma, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse drug reaction as a measure of safety and tolerability. (time frame: Up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.