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Sorafenib

Generic Name
Sorafenib
Brand Names
Nexavar, Sorafenib Accord
Drug Type
Small Molecule
Chemical Formula
C21H16ClF3N4O3
CAS Number
284461-73-0
Unique Ingredient Identifier
9ZOQ3TZI87
Background

Sorafenib is a bi-aryl urea and an oral multikinase inhibitor. It targets cell surface tyrosine kinase receptors and downstream intracellular kinases that are implicated in tumour cell proliferation and tumour angiogenesis. First approved by the FDA and European Commission in 2007 for the treatment of hepatocellular carcinoma, sorafenib is also indicated to treat renal carcinoma and differentiated thyroid carcinoma.

Indication

Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

In the US, it is also indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Associated Conditions
Advanced Renal Cell Carcinoma, Angiosarcoma, Gastrointestinal Stromal Tumor (GIST), Leiomyosarcoma (LMS), Unresectable Hepatocellular Carcinoma (HCC), Progressive, locally recurrent radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC), Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC)
Clinical Trials
Related News

Research Study for Patients With Metastatic Renal Cell Carcinoma

Phase 2
Terminated
Conditions
Carcinoma, Renal Cell
Interventions
Drug: Placebo
First Posted Date
2005-05-09
Last Posted Date
2013-10-11
Lead Sponsor
Bayer
Target Recruit Count
1
Registration Number
NCT00110344

Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

Phase 3
Completed
Conditions
Recurrent Melanoma
Stage IIIC Skin Melanoma
Mucosal Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IV Skin Melanoma
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo
First Posted Date
2005-05-04
Last Posted Date
2015-10-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
823
Registration Number
NCT00110019
Locations
🇺🇸

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

🇺🇸

Bay Area Tumor Institute, Oakland, California, United States

🇺🇸

Kaiser Permanente-Redwood City, Redwood City, California, United States

and more 216 locations

A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

Phase 2
Completed
Conditions
Carcinoma, Hepatocellular
Interventions
Drug: Doxorubicin/Placebo
First Posted Date
2005-04-22
Last Posted Date
2014-10-31
Lead Sponsor
Bayer
Target Recruit Count
96
Registration Number
NCT00108953

Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.

Phase 2
Completed
Conditions
Epithelial Mesothelioma
Recurrent Malignant Mesothelioma
Sarcomatous Mesothelioma
Stage IA Malignant Mesothelioma
Stage IB Malignant Mesothelioma
Stage II Malignant Mesothelioma
Stage III Malignant Mesothelioma
Stage IV Malignant Mesothelioma
Interventions
Other: laboratory biomarker analysis
First Posted Date
2005-04-06
Last Posted Date
2013-06-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
44
Registration Number
NCT00107432
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Cancer and Leukemia Group B, Chicago, Illinois, United States

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Phase 3
Completed
Conditions
Carcinoma, Hepatocellular
Interventions
Drug: Placebo
First Posted Date
2005-03-15
Last Posted Date
2014-10-31
Lead Sponsor
Bayer
Target Recruit Count
602
Registration Number
NCT00105443

BAY43-9006 - Phase II Study in Non-Small Cell Lung Carcinoma (NSCLC)

Phase 2
Completed
Conditions
Carcinoma, Non-Small Cell Lung
Cancer
Interventions
First Posted Date
2005-01-11
Last Posted Date
2013-10-30
Lead Sponsor
Bayer
Target Recruit Count
52
Registration Number
NCT00101413

BAY43-9006 - Phase II in Advanced Breast Cancer

Phase 2
Completed
Conditions
Breast Neoplasms
Breast Cancer
Interventions
First Posted Date
2005-01-11
Last Posted Date
2013-12-13
Lead Sponsor
Bayer
Target Recruit Count
54
Registration Number
NCT00101400

Sorafenib and Interferon Alfa in Treating Patients With Metastatic or Unresectable Kidney Cancer

Phase 2
Completed
Conditions
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions
Biological: recombinant interferon alfa-2b
Other: laboratory biomarker analysis
First Posted Date
2005-01-10
Last Posted Date
2013-02-28
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
55
Registration Number
NCT00101114
Locations
🇺🇸

Southwest Oncology Group, San Antonio, Texas, United States

Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Phase 2
Terminated
Conditions
Clear Cell Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions
Biological: recombinant interferon alfa
Other: laboratory biomarker analysis
First Posted Date
2004-12-08
Last Posted Date
2013-07-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
40
Registration Number
NCT00098618
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Interventions
Other: laboratory biomarker analysis
First Posted Date
2004-12-08
Last Posted Date
2016-12-29
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
46
Registration Number
NCT00098540
Locations
🇺🇸

North Central Cancer Treatment Group, Rochester, Minnesota, United States

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