Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT02185560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2014-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JPMS-DTC
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NEXAVAR-TC-01 | OTHER | Company Internal | View |