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 Breast Cancer

Phase 2

Completed

Conditions: Male Breast Cancer
Stage IV Breast Cancer
Recurrent Breast Cancer

Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis

First Posted Date: 2004-11-10

Last Posted Date: 2024-03-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 23

Registration Number: NCT00096434

Locations: 🇺🇸
North Central Cancer Treatment Group, Rochester, Minnesota, United States

S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Phase 2

Completed

Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx

Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis

First Posted Date: 2004-11-10

Last Posted Date: 2013-02-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT00096512

Locations: 🇺🇸
Southwest Oncology Group (SWOG) Research Base, San Antonio, Texas, United States

Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Phase 2

Completed

Conditions: Recurrent Ovarian Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Primary Peritoneal Carcinoma

Interventions: Drug: Sorafenib Tosylate
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2004-11-09

Last Posted Date: 2022-02-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 44

Registration Number: NCT00096200

Locations: 🇺🇸
Moffitt Cancer Center at Tampa General Hospital, Tampa, Florida, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States

and more 2 locations

Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

Interventions: Drug: sorafenib tosylate
Drug: gemcitabine hydrochloride

First Posted Date: 2004-11-09

Last Posted Date: 2013-07-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT00095966

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer

Phase 2

Completed

Conditions: Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer

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

First Posted Date: 2004-11-09

Last Posted Date: 2013-06-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 33

Registration Number: NCT00096395

Locations: 🇨🇦
Princess Margaret Hospital Phase 2 Consortium, Toronto, Ontario, Canada

Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer

Phase 2

Terminated

Conditions: Anaplastic Thyroid Cancer
Insular Thyroid Cancer
Recurrent Thyroid Cancer
Stage III Follicular Thyroid Cancer
Stage III Papillary Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IV Papillary Thyroid Cancer

Interventions: Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Other: pharmacological study
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: dynamic contrast-enhanced magnetic resonance imaging

First Posted Date: 2004-11-08

Last Posted Date: 2014-01-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 25

Registration Number: NCT00095693

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

BAY 43-9006 (Sorafenib) and Bevacizumab (Avastin) To Treat Solid Tumors

Phase 1

Completed

Conditions: Neoplasms

First Posted Date: 2004-11-05

Last Posted Date: 2019-12-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 57

Registration Number: NCT00095459

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

Phase 2

Completed

Conditions: Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Sorafenib Tosylate

First Posted Date: 2004-10-08

Last Posted Date: 2019-07-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 73

Registration Number: NCT00093626

Locations: 🇺🇸
Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma

Phase 1

Completed

Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor

Interventions: Drug: sorafenib tosylate
Other: pharmacological study

First Posted Date: 2004-10-08

Last Posted Date: 2014-05-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 47

Registration Number: NCT00093613

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Henry Ford Hospital, Detroit, Michigan, United States

and more 7 locations

Sorafenib in Treating Patients With Metastatic or Recurrent Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

First Posted Date: 2004-10-08

Last Posted Date: 2023-08-04

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 28

Registration Number: NCT00093457

Locations: 🇨🇦
CancerCare Manitoba, Winnipeg, Manitoba, Canada
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

and more 4 locations

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