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)

Associated Therapies: -

Clinical Trials

Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma

Phase 3

Completed

Conditions: Child-Pugh A Hepatocellular Carcinoma

Interventions: Drug: Sorafenib + Pravastatin
Drug: Sorafenib

First Posted Date: 2013-07-19

Last Posted Date: 2014-05-13

Lead Sponsor: Centre Hospitalier Universitaire Dijon

Target Recruit Count: 474

Registration Number: NCT01903694

Locations: 🇫🇷
CHU de Dijon, Dijon, France

Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Radiation: TACE+External beam RT
Drug: Sorafenib

First Posted Date: 2013-07-17

Last Posted Date: 2017-09-18

Lead Sponsor: Asan Medical Center

Target Recruit Count: 90

Registration Number: NCT01901692

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

Sorafenib Tosylate and Yttrium Y 90 Glass Microspheres in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Phase 2

Completed

Conditions: Advanced Adult Hepatocellular Carcinoma
Stage IIIA Hepatocellular Carcinoma AJCC v7
Stage IVB Hepatocellular Carcinoma AJCC v7
Stage IIIC Hepatocellular Carcinoma AJCC v7
Stage IV Hepatocellular Carcinoma AJCC v7
Stage IVA Hepatocellular Carcinoma AJCC v7
BCLC Stage C Hepatocellular Carcinoma
Recurrent Adult Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v7
Stage IIIB Hepatocellular Carcinoma AJCC v7

Interventions: Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Drug: Sorafenib
Drug: Sorafenib Tosylate
Radiation: Yttrium Y 90 Glass Microspheres

First Posted Date: 2013-07-16

Last Posted Date: 2021-12-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT01900002

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma

Phase 1

Completed

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: Onartuzumab
Drug: Sorafenib

First Posted Date: 2013-07-11

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 9

Registration Number: NCT01897038

Sorafenib and Radioembolization With Sir-Spheres® for the Treatment of Metastatic Ocular Melanoma

Phase 1

Completed

Conditions: Ocular Melanoma

Interventions: Drug: Sorafenib
Device: Radioembolization with SIR-Spheres® (Yttrium Microspheres)

First Posted Date: 2013-07-08

Last Posted Date: 2018-04-23

Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Target Recruit Count: 11

Registration Number: NCT01893099

Locations: 🇨🇭
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein

Phase 3

Terminated

Conditions: Hepatocellular Carcinoma

Interventions: Device: TheraSphere®
Drug: Sorafenib

First Posted Date: 2013-06-27

Last Posted Date: 2021-04-21

Lead Sponsor: Boston Scientific Corporation

Target Recruit Count: 36

Registration Number: NCT01887717

Locations: 🇺🇸
Northwestern Medical Faculty Foundation, Div of Hematology/Oncology, Chicago, Illinois, United States
🇫🇷
Paoli-Calmettes Institute, Marseille, France
🇧🇪
Cliniques Universitaires Saint-Luc, Brussels, Belgium

and more 16 locations

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Phase 2

Active, not recruiting

Conditions: Rhabdomyosarcoma

Interventions: Drug: Vincristine
Drug: Dactinomycin
Drug: Cyclophosphamide
Procedure: Surgical Resection
Procedure: Radiation
Drug: Myeloid Growth Factor
Drug: Bevacizumab
Procedure: Lymph Node Sampling
Drug: Sorafenib
Drug: ^1^1C-methionine
Drug: Irinotecan
Drug: Ifosfamide
Drug: Etoposide
Drug: Etoposide Phosphate
Drug: Doxorubicin
Drug: Dexrazoxane

First Posted Date: 2013-06-07

Last Posted Date: 2024-08-09

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 98

Registration Number: NCT01871766

Locations: 🇺🇸
Nemours Children's Clinic, Jacksonville, Florida, United States
🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇺🇸
University of Florida Proton Therapy Institute, Jacksonville, Florida, United States

and more 1 locations

HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)

Phase 4

Terminated

Conditions: Hepatocellular Cancer

Interventions: Drug: Sorafenib

First Posted Date: 2013-05-08

Last Posted Date: 2017-04-19

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 3

Registration Number: NCT01849588

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Phase I Study With Sorafenib in Addition to Vinflunine in Metastatic Transitional Cell Carcinoma of the Urothelial Tract

Phase 1

Completed

Conditions: Bladder Cancer
Ureter Cancer
Urethra Cancer
Urothelial Carcinoma
Renal Pelvis Cancer

Interventions: Drug: Vinflunine
Drug: Sorafenib

First Posted Date: 2013-05-03

Last Posted Date: 2019-04-26

Lead Sponsor: Dr Anders Ullén

Target Recruit Count: 22

Registration Number: NCT01844947

Locations: 🇩🇰
Department of Oncology, Rigshospitalet, Copenhagen, Denmark
🇸🇪
Department of Oncology, Karolinska University Hospital, Stockholm, Sweden
🇩🇰
Department of Oncology, Aarhus University Hospital, Aarhus, Denmark

Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Sorafenib
Drug: Doxorubicin

First Posted Date: 2013-04-25

Last Posted Date: 2024-05-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 30

Registration Number: NCT01840592

Locations: 🇺🇸
Memorial Sloan Kettering West Harrison, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

and more 3 locations

Drug Development Updates

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