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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)

A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2004-08-27
Last Posted Date
2018-06-14
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
46
Registration Number
NCT00090545
Locations
🇺🇸

National Cancer Institute (NCI), Bethesda, Maryland, United States

Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

Phase 2
Completed
Conditions
Carcinoma, Renal Cell
Interventions
First Posted Date
2004-03-11
Last Posted Date
2014-12-19
Lead Sponsor
Bayer
Target Recruit Count
501
Registration Number
NCT00079612

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

Phase 3
Completed
Conditions
Carcinoma, Renal Cell
Interventions
First Posted Date
2003-11-21
Last Posted Date
2014-02-06
Lead Sponsor
Bayer
Target Recruit Count
903
Registration Number
NCT00073307

Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
Drug: Placebo
First Posted Date
2003-07-09
Last Posted Date
2023-06-29
Lead Sponsor
Eastern Cooperative Oncology Group
Target Recruit Count
342
Registration Number
NCT00064350
Locations
🇺🇸

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States

🇺🇸

Memorial Hospital, Carthage, Illinois, United States

🇺🇸

St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States

and more 138 locations

A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

Phase 2
Completed
Conditions
Carcinoma, Hepatocellular
Interventions
First Posted Date
2002-09-04
Last Posted Date
2014-04-16
Lead Sponsor
Bayer
Target Recruit Count
137
Registration Number
NCT00044512
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