MedPath

Sorafenib

Generic Name
Sorafenib
Brand Names
Nexavar, Sorafenib Accord
Drug Type
Small Molecule
Chemical Formula
C21H16ClF3N4O3
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)

A Study to Assess the Pharmacokinetics of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers

Early Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2025-01-28
Last Posted Date
2025-03-17
Lead Sponsor
Disruptive Pharma
Target Recruit Count
12
Registration Number
NCT06797427
Locations
🇸🇪

Clinical Trial Consultants (CTC), Dag Hammarskjölds väg 10B, Uppsala, Sweden

IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients

Phase 1
Recruiting
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2025-01-09
Last Posted Date
2025-01-09
Lead Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
Target Recruit Count
24
Registration Number
NCT06765005
Locations
🇨🇳

Hangzhou First People's Hospital;, Hangzhou, Zhejiang, China

Combination of Toripalimab and JS004 Therapy for ccRCC

Phase 2
Recruiting
Conditions
Clear Cell Renal Cell Carcinoma
Interventions
First Posted Date
2024-11-15
Last Posted Date
2024-11-15
Lead Sponsor
Fudan University
Target Recruit Count
80
Registration Number
NCT06690697
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia, in Relapse
Myelodysplastic Syndromes
Chronic Myeloid Leukemia
Myeloproliferative Neoplasm
Interventions
First Posted Date
2024-08-01
Last Posted Date
2024-08-01
Lead Sponsor
St. Petersburg State Pavlov Medical University
Target Recruit Count
88
Registration Number
NCT06532084
Locations
🇷🇺

RM Gorbacheva Research Institute, Saint Petersburg, Russian Federation

Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

Phase 1
Recruiting
Conditions
Hepatocellular Carcinoma
HCC
Interventions
First Posted Date
2024-07-30
Last Posted Date
2024-07-30
Lead Sponsor
Assiut University
Target Recruit Count
150
Registration Number
NCT06527495
Locations
🇪🇬

NLI, Shibīn Al Kawm, Menoufia, Egypt

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

First Posted Date
2024-07-01
Last Posted Date
2024-12-05
Lead Sponsor
West China Hospital
Target Recruit Count
75
Registration Number
NCT06482086
Locations
🇨🇳

West China hospital, Chengdu, Sichuan, China

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating with Decitabine in Pediatric Relapsed and Refractory Acute Leukemias

Phase 1
Not yet recruiting
Conditions
Refractory Acute Leukemia
Relapsed Acute Leukemia
Interventions
First Posted Date
2024-06-26
Last Posted Date
2025-02-05
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT06474663
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Phase 2 Study of WGI-0301 for Advanced HCC

Phase 2
Not yet recruiting
Conditions
Advanced Hepatocellular Carcinoma (HCC)
Interventions
Drug: WGI-0301 at MTD/RP2D dose IV infusion, QW
Drug: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW
First Posted Date
2024-03-13
Last Posted Date
2024-08-12
Lead Sponsor
Zhejiang Haichang Biotech Co., Ltd.
Target Recruit Count
60
Registration Number
NCT06309485

Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus

Phase 2
Not yet recruiting
Conditions
Type 1 Diabetes
Interventions
Drug: Placebo
First Posted Date
2024-01-26
Last Posted Date
2025-01-13
Lead Sponsor
Second Xiangya Hospital of Central South University
Target Recruit Count
10
Registration Number
NCT06227221

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

Phase 2
Recruiting
Conditions
AML, Childhood
Acute Myeloid Leukemia
Interventions
First Posted Date
2024-01-24
Last Posted Date
2024-08-22
Lead Sponsor
Children's Hospital of Soochow University
Target Recruit Count
500
Registration Number
NCT06221683
Locations
🇨🇳

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

🇨🇳

XiangYa Hospital Central South University, Changsha, Hunan, China

🇨🇳

Children's Hospital of Soochow University, Suzhou, Jiangsu, China

and more 10 locations
© Copyright 2025. All Rights Reserved by MedPath