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

Learn more about:
Related Clinical Trial
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule Optimising Molecular Radionuclide Therapy Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer Function Integrity of Neck Anatomy in Thyroid Surgery An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer Undergoing Radiation Therapy and/or Systemic Therapy Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System Evaluation of a New CZT System Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain A Study Into the Effect of Seprafilm in Open Total Thyroidectomy Lenvatinib and Pembrolizumab in DTC Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies Genomic Profiling of Nodular Thyroid Disease and Thyroid Cancer Comparative Study of Robot BABA Approach and Chest Breast Approach for Lateral Neck Dissection Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer Influence of Thyroid Hormones on the Woundhealing Process ctDNA in Patients With Thyroid Nodules Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine Trial of LBH589 in Metastatic Thyroid Cancer Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma Study of Sulfatinib in Treating Advanced Medullary Thyroid Carcinoma and Iodine-refractory Differentiated Thyroid Carcinoma Thyroid Cancer and Sunitinib Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients Lipid Metabolic Status in Thyroid Carcinoma

Brief Title

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

Official Title

Drug Use Investigation of Sorafenib/ NEXAVAR® for Unresectable Differentiated Thyroid Carcinoma (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.
    



Study Type

Observational


Primary Outcome

Number of participants with Adverse drug reaction as a measure of safety and tolerability.

Secondary Outcome

 2-year survival

Condition

Thyroid Carcinoma

Intervention

Sorafenib (Nexavar, BAY43-9006)

Study Arms / Comparison Groups

 BAY43-9006
Description:  NEXAVAR treatment group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

453

Start Date

June 27, 2014

Completion Date

June 30, 2024

Primary Completion Date

February 27, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02185560

Organization ID

17391

Secondary IDs

NEXAVAR-TC-01

Responsible Party

Sponsor

Study Sponsor

Bayer


Study Sponsor

Bayer Study Director, Study Director, Bayer


Verification Date

October 2021