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

Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer

Phase 1

Withdrawn

Conditions: Hepatocellular Cancer

Interventions: Drug: Sorafenib
Radiation: yttrium-90 radioembolization

First Posted Date: 2014-11-11

Last Posted Date: 2019-11-08

Lead Sponsor: University of Hawaii

Registration Number: NCT02288507

Locations: 🇺🇸
University of Hawaii, Honolulu, Hawaii, United States

A Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma

Phase 1

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: BBI608
Drug: BBI503
Drug: Sorafenib

First Posted Date: 2014-10-31

Last Posted Date: 2023-11-15

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 97

Registration Number: NCT02279719

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸
Piedmont Cancer Institute, P.C., Atlanta, Georgia, United States

and more 26 locations

Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Crenolanib
Drug: Sorafenib
Drug: methotrexate, hydrocortisone and cytarabine with leucovorin

First Posted Date: 2014-10-21

Last Posted Date: 2017-10-03

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 10

Registration Number: NCT02270788

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

A Study of LY2157299 in Participants With Unresectable Hepatocellular Cancer (HCC)

Phase 1

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: LY2157299
Drug: Sorafenib

First Posted Date: 2014-09-15

Last Posted Date: 2020-02-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 9

Registration Number: NCT02240433

Locations: 🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Suita-shi, Japan

Phase 1b/2 Study of Oprozomib in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma

Phase 1

Withdrawn

Conditions: Advanced Hepatocellular Carcinoma

Interventions: Drug: Oprozomib
Drug: Sorafenib

First Posted Date: 2014-08-28

Last Posted Date: 2017-05-02

Lead Sponsor: Amgen

Registration Number: NCT02227914

Locations: 🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Lahey Hospital & Medical Center, Burlington, California, United States
🇺🇸
The Ohio State University, Martha Morehouse Medical Plaza, Columbus, Ohio, United States

and more 3 locations

The Efficacy and Safety of Retreatment With TAI for Patients Who Showed TACE-resistant: a Randomized Controlled Trial

Phase 2

Terminated

Conditions: Hepatocellular Carcinoma

Interventions: Procedure: TAI of FOLFOX
Drug: Sorafenib

First Posted Date: 2014-08-19

Last Posted Date: 2019-01-11

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 79

Registration Number: NCT02220088

Locations: 🇨🇳
Cancer Center Sun Yat-sen University, Guangzhou, Guangdong, China

Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Azacytidine
Drug: Sorafenib

First Posted Date: 2014-07-22

Last Posted Date: 2020-01-14

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT02196857

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: LY2157299
Drug: Sorafenib
Drug: Placebo

First Posted Date: 2014-06-30

Last Posted Date: 2022-02-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 132

Registration Number: NCT02178358

Locations: 🇹🇭
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bangkok, Thailand

Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors

Phase 1

Completed

Conditions: Refractory Malignant Neoplasm
Metastatic Malignant Solid Neoplasm
Cirrhosis
Unresectable Solid Neoplasm
Stage IV Hepatocellular Carcinoma AJCC v7
Hepatitis B Infection
Hepatitis C Infection
Recurrent Hepatocellular Carcinoma
Recurrent Malignant Solid Neoplasm

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

First Posted Date: 2014-05-21

Last Posted Date: 2024-11-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 29

Registration Number: NCT02143401

Locations: 🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

and more 7 locations

Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer

Phase 2

Conditions: Refractory Hurthle Cell Thyroid Cancer

Interventions: Drug: sorafenib
Drug: everolimus

First Posted Date: 2014-05-21

Last Posted Date: 2022-04-04

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 35

Registration Number: NCT02143726

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Nebraska Methodist Hospital, Omaha, Nebraska, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

and more 18 locations

Drug Development Updates

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