Sorafenib

Generic Name: Sorafenib

Brand Names: Nexavar, Sorafenib Accord

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₆ClF_₃N_₄O_₃

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

Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006

Phase 1

Completed

Conditions: Kidney Diseases

Interventions: Drug: Sorafenib (BAY43-9006, Nexavar)

First Posted Date: 2005-07-14

Last Posted Date: 2009-01-16

Lead Sponsor: Bayer

Target Recruit Count: 32

Registration Number: NCT00119639

Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Stage III Melanoma
Stage IV Melanoma

Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-07-13

Last Posted Date: 2013-01-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 74

Registration Number: NCT00119249

Locations: 🇺🇸
Montefiore Medical Center, Bronx, New York, United States

Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function

Phase 1

Completed

Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Grade 3 Follicular Lymphoma
Splenic Marginal Zone Lymphoma
Stage III Marginal Zone Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Mantle Cell Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma

Interventions: Drug: sorafenib tosylate
Other: pharmacological study

First Posted Date: 2005-07-11

Last Posted Date: 2013-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 150

Registration Number: NCT00118170

Locations: 🇺🇸
Cancer and Leukemia Group B (CALGB) Research Base, Chicago, Illinois, United States

BAY43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma

Phase 2

Completed

Conditions: Carcinoma, Renal Cell

Interventions: Drug: Interferon
Drug: Sorafenib (Nexavar, BAY43-9006)

First Posted Date: 2005-07-08

Last Posted Date: 2014-10-31

Lead Sponsor: Bayer

Target Recruit Count: 189

Registration Number: NCT00117637

Sorafenib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Stage IV Pancreatic Cancer

Interventions: Drug: sorafenib tosylate
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2005-06-14

Last Posted Date: 2015-01-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 52

Registration Number: NCT00114244

Locations: 🇺🇸
City of Hope, Duarte, California, United States

Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium

Phase 2

Terminated

Conditions: Adenocarcinoma of the Bladder
Distal Urethral Cancer
Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Squamous Cell Carcinoma of the Bladder
Stage III Bladder Cancer

Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-06-03

Last Posted Date: 2014-05-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 27

Registration Number: NCT00112905

Locations: 🇺🇸
Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

Sorafenib in Treating Patients With Advanced or Metastatic Cancer of the Urinary Tract

Phase 2

Completed

Conditions: Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
Transitional Cell Carcinoma of the Bladder
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Stage III Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Bladder Cancer
Stage IV Bladder Cancer