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

Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

Phase 2

Completed

Conditions: Adult Angiosarcoma
Adult Neurofibrosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Adult Epithelioid Sarcoma
Adult Leiomyosarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma

Interventions: Drug: sorafenib tosylate

First Posted Date: 2005-10-27

Last Posted Date: 2014-05-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 147

Registration Number: NCT00245102

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Tipifarnib and Sorafenib Tosylate in Treating Patients With Biopsiable Advanced Cancer

Phase 1

Completed

Conditions: Advanced Malignant Neoplasm

Interventions: Other: Laboratory Biomarker Analysis
Drug: Sorafenib Tosylate
Drug: Tipifarnib

First Posted Date: 2005-10-27

Last Posted Date: 2017-04-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 74

Registration Number: NCT00244972

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

S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma

Phase 2

Completed

Conditions: Adenocarcinoma of the Extrahepatic Bile Duct
Adenocarcinoma of the Gallbladder
Adenocarcinoma With Squamous Metaplasia of the Gallbladder
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Squamous Cell Carcinoma of the Gallbladder
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer

Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-10-13

Last Posted Date: 2013-01-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT00238212

Locations: 🇺🇸
Southwest Oncology Group, San Antonio, Texas, United States

Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer

Phase 2

Completed

Conditions: Stage III Uterine Sarcoma
Uterine Carcinosarcoma
Stage IV Uterine Sarcoma
Recurrent Uterine Sarcoma

Interventions: Drug: sorafenib tosylate

First Posted Date: 2005-10-13

Last Posted Date: 2015-11-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 56

Registration Number: NCT00238121

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

and more 4 locations

S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

Phase 2

Completed

Conditions: Sarcoma

Interventions: Drug: sorafenib

First Posted Date: 2005-09-22

Last Posted Date: 2014-05-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 51

Registration Number: NCT00217620

Locations: 🇺🇸
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
🇺🇸
West Michigan Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
Bronson Methodist Hospital, Kalamazoo, Michigan, United States

and more 179 locations

Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

Phase 1

Completed

Conditions: Stage IV Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: sorafenib tosylate
Drug: anastrozole

First Posted Date: 2005-09-22

Last Posted Date: 2014-05-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT00217399

Locations: 🇺🇸
Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia, United States

Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia

Phase 1

Completed

Conditions: Adult Acute Eosinophilic Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myelomonocytic Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA

Interventions: Drug: Sorafenib Tosylate

First Posted Date: 2005-09-22

Last Posted Date: 2015-04-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 36

Registration Number: NCT00217646

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

Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Phase 2

Completed

Conditions: Head and Neck Neoplasms

First Posted Date: 2005-09-20

Last Posted Date: 2015-05-20

Lead Sponsor: Jules Bordet Institute

Target Recruit Count: 60

Registration Number: NCT00199160

Locations: 🇧🇪
Jules Bordet Institute, Brussels, Belgium

Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer

Phase 2

Completed

Conditions: Extensive Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer

Interventions: Drug: sorafenib tosylate

First Posted Date: 2005-09-16

Last Posted Date: 2014-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 89

Registration Number: NCT00182689

Locations: 🇺🇸
SWOG, Portland, Oregon, United States

Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Stage III Rectal Cancer
Stage IV Colon Cancer
Stage IV Rectal Cancer
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage III Colon Cancer

Interventions: Drug: sorafenib tosylate
Drug: cetuximab
Drug: irinotecan hydrochloride

First Posted Date: 2005-08-24

Last Posted Date: 2014-04-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT00134069

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
University of Colorado at Denver Health Sciences Center, Aurora, Colorado, United States

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