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

CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer

Phase 2

Completed

Conditions: Advanced Hepatocellular Carcinoma
Liver Cancer
Hepatic Cancer
Liver Neoplasms

Interventions: Drug: CS-1008 2 mg/kg
Drug: Sorafenib
Drug: CS-1008 4 mg/kg
Drug: CS-1008 6 mg/kg
Drug: CS-1008 6/2 mg/kg
Drug: CS-1008 6/6 mg/kg

First Posted Date: 2009-12-16

Last Posted Date: 2021-04-08

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 172

Registration Number: NCT01033240

Locations: 🇺🇸
Kenmar Research Group, Los Angeles, California, United States
🇯🇵
Hiroshima University, Hiroshima-city, Hiroshima, Japan
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

and more 25 locations

A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

Phase 3

Completed

Conditions: Advanced Renal Cell Carcinoma

Interventions: Drug: tivozanib (AV-951)
Drug: Sorafenib

First Posted Date: 2009-12-11

Last Posted Date: 2019-10-28

Lead Sponsor: AVEO Pharmaceuticals, Inc.

Target Recruit Count: 517

Registration Number: NCT01030783

Locations: 🇮🇳
Site 155, Jaipur, Rajasthan, India
🇮🇳
Site 191, Jaipur, Rajasthan, India
🇮🇳
Site 152, Vellore, Tamil Nadu, India

and more 83 locations

Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

Phase 3

Terminated

Conditions: Hepatocellular Carcinoma Non-resectable
Hepatocellular Carcinoma Recurrent
Carcinoma, Hepatocellular
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site

Interventions: Drug: ABT-869
Drug: Sorafenib

First Posted Date: 2009-11-06

Last Posted Date: 2012-09-10

Lead Sponsor: Abbott

Target Recruit Count: 1035

Registration Number: NCT01009593

Locations: 🇺🇸
Site Reference ID/Investigator# 24848, Honolulu, Hawaii, United States
🇺🇸
Site Reference ID/Investigator# 23609, Honolulu, Hawaii, United States
🇺🇸
Site Reference ID/Investigator# 23250, Louisville, Kentucky, United States

and more 160 locations

Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

Not Applicable

Terminated

Conditions: Liver Cancer
Hepatocellular Carcinoma

Interventions: Drug: Sorafenib
Radiation: Stereotactic Body Radiotherapy (SBRT)

First Posted Date: 2009-11-01

Last Posted Date: 2017-05-10

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 5

Registration Number: NCT01005875

Locations: 🇺🇸
UAB, Birmingham, Alabama, United States

Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: BIBF 1120
Drug: Sorafenib

First Posted Date: 2009-10-29

Last Posted Date: 2017-10-26

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 125

Registration Number: NCT01004003

Locations: 🇫🇷
1199.37.33002 Boehringer Ingelheim Investigational Site, Paris, France
🇩🇪
1199.37.49003 Boehringer Ingelheim Investigational Site, München, Germany
🇵🇱
1199.37.48003 Boehringer Ingelheim Investigational Site, Warsaw, Poland

and more 25 locations

Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer

Phase 1

Conditions: Hepatocellular Carcinoma

First Posted Date: 2009-10-22

Last Posted Date: 2009-10-22

Lead Sponsor: Fudan University

Target Recruit Count: 30

Registration Number: NCT00999843

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients

Phase 1

Completed

Conditions: Hepatocellular Cancer

Interventions: Drug: Sorafenib

First Posted Date: 2009-10-16

Last Posted Date: 2015-08-10

Lead Sponsor: Columbia University

Target Recruit Count: 14

Registration Number: NCT00997022

Locations: 🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
Columbia University Medical Center, New York, New York, United States

A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients

Phase 2

Completed

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: BIBF 1120
Drug: Sorafenib

First Posted Date: 2009-10-01

Last Posted Date: 2016-03-10

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 134

Registration Number: NCT00987935

Locations: 🇨🇳
1199.39.88604 Boehringer Ingelheim Investigational Site, Taoyuan County, Taiwan
🇨🇳
1199.39.88606 Boehringer Ingelheim Investigational Site, Changhua, Taiwan
🇨🇳
1199.39.88603 Boehringer Ingelheim Investigational Site, Taipei, Taiwan

and more 13 locations

Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)

Phase 1

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: GC33(RO5137382)
Drug: Sorafenib

First Posted Date: 2009-09-14

Last Posted Date: 2014-10-03

Lead Sponsor: Chugai Pharmaceutical

Target Recruit Count: 42

Registration Number: NCT00976170

Locations: 🇺🇸
California Pacific Medical Center, San Francisco, California, United States
🇨🇳
National Taiwan Univercity Hospital, Taipei, Taiwan
🇺🇸
University of Miami, Miami, Florida, United States

and more 4 locations

Depocyt® With Sorafenib in Neoplastic Meningitis

Not Applicable

Terminated

Conditions: Neoplastic Meningitis

Interventions: Drug: DepoCyt
Drug: Sorafenib

First Posted Date: 2009-08-25

Last Posted Date: 2013-09-09

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 2

Registration Number: NCT00964743

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

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