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

Sponsor
Bayer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02185560
Collaborator
(none)
453
1
120.1
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sorafenib (Nexavar, BAY43-9006)

Study Design

Study Type:
Observational
Actual Enrollment :
453 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (DTC)
Actual Study Start Date :
Jun 27, 2014
Actual Primary Completion Date :
Feb 27, 2020
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
BAY43-9006

NEXAVAR treatment group

Drug: Sorafenib (Nexavar, BAY43-9006)
Patients treated by Physician with Nexavar under approved local prescriptions

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Adverse drug reaction as a measure of safety and tolerability. [Up to 9 months]

  2. Number of participants with Serious adverse events as a measure of safety and tolerability. [Up to 9 months]

  3. Number of participants with Serious adverse drug reaction as a measure of safety and tolerability [Up to 9 months]

Secondary Outcome Measures

  1. 2-year survival [At 24 months]

    Percentage of participants who survived 2 years from start of treatment

  2. Time of treatment failure (TTF) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Multiple Locations Japan

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02185560
Other Study ID Numbers:
  • 17391
  • NEXAVAR-TC-01
First Posted:
Jul 9, 2014
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022

Study Results

No Results Posted as of Aug 19, 2022