do_not_disturb_altRecruitment Complete

Thyroid Carcinoma

Bayer Identifier:

17391

ClinicalTrials.gov Identifier:

NCT02185560

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prospective, non-interventional, post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma and treated with Sorafenib

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)

  • - Patients who have already received NEXAVAR treatment

Trial summary

Enrollment Goal
453
Trial Dates
June 2014 - June 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many Locations, Japan

Primary Outcome

  • Number of participants with Adverse drug reaction as a measure of safety and tolerability.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with Serious adverse events as a measure of safety and tolerability.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with Serious adverse drug reaction as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • 2-year survival
    Percentage of participants who survived 2 years from start of treatment
    date_rangeTime Frame:
    At 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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