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 Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Hepatosplenic T-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Interventions: Drug: sorafenib tosylate

First Posted Date: 2005-08-19

Last Posted Date: 2015-09-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT00131937

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

Sorafenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia

Phase 1

Completed

Conditions: Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Interventions: Drug: sorafenib tosylate
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2005-08-19

Last Posted Date: 2013-01-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT00131989

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

Phase 2

Completed

Conditions: Recurrent Gastrointestinal Carcinoid Tumor
Gastrinoma
Neuroendocrine Tumor
Pancreatic Polypeptide Tumor
Somatostatinoma
Glucagonoma
Metastatic Gastrointestinal Carcinoid Tumor
WDHA Syndrome
Insulinoma
Recurrent Islet Cell Carcinoma

Interventions: Drug: sorafenib tosylate

First Posted Date: 2005-08-19

Last Posted Date: 2014-11-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 93

Registration Number: NCT00131911

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: erlotinib hydrochloride
Drug: sorafenib tosylate

First Posted Date: 2005-08-04

Last Posted Date: 2015-07-23

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 17

Registration Number: NCT00126620

Locations: 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada

Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer

Phase 2

Terminated

Conditions: Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Clear Cell Renal Cell Carcinoma

Interventions: Procedure: therapeutic conventional surgery
Drug: sorafenib tosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-08-04

Last Posted Date: 2018-11-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 10

Registration Number: NCT00126659

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

Sorafenib in Treating Patients With Advanced Anaplastic Thyroid Cancer

Phase 2

Terminated

Conditions: Anaplastic Thyroid Cancer
Recurrent Thyroid Cancer

Interventions: Drug: sorafenib tosylate

First Posted Date: 2005-08-04

Last Posted Date: 2018-01-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT00126568

Locations: 🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States

Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Phase 2

Completed

Conditions: Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Clear Cell Renal Cell Carcinoma

Interventions: Drug: Sorafenib Tosylate
Biological: Recombinant Interferon Alfa-2b
Other: Laboratory Biomarker Analysis

First Posted Date: 2005-08-04

Last Posted Date: 2016-09-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 80

Registration Number: NCT00126594

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

Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer

Phase 1

Completed

Conditions: Chromophobe Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Papillary Renal Cell Carcinoma
Recurrent Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Stage IV Renal Cell Cancer

Interventions: Biological: Bevacizumab
Drug: Sorafenib Tosylate
Other: Pharmacological Study
Other: Laboratory Biomarker Analysis

First Posted Date: 2005-08-04

Last Posted Date: 2015-01-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 73

Registration Number: NCT00126503

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Harvard Cancer Center, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 2 locations

17-AAG and Sorafenib in Treating Patients With Unresectable or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: sorafenib tosylate
Drug: tanespimycin
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: magnetic resonance imaging

First Posted Date: 2005-07-21

Last Posted Date: 2014-06-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 54

Registration Number: NCT00121264

Locations: 🇺🇸
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Sorafenib, Gemcitabine, and Capecitabine in Treating Patients With Unresectable and/or Metastatic Kidney Cancer

Phase 1

Completed

Conditions: Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v7
Stage III Renal Cell Cancer AJCC v7

Interventions: Drug: Capecitabine
Drug: Gemcitabine Hydrochloride
Drug: Sorafenib Tosylate

First Posted Date: 2005-07-21

Last Posted Date: 2021-04-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT00121251

Locations: 🇺🇸
Weill Medical College of Cornell University, New York, New York, United States
🇺🇸
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
🇺🇸
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

and more 1 locations

Drug Development Updates

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