Regorafenib

Generic Name: Regorafenib

Brand Names: Stivarga

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₅ClF_₄N_₄O_₃

CAS Number: 755037-03-7

Unique Ingredient Identifier: 24T2A1DOYB

Background: Regorafenib is an orally-administered inhibitor of multiple kinases. It is used for the treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumours, and hepatocellular carcinoma. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017.

Indication: Regorafenib is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Regorafenib is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumour (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Regorafenib is also indicated for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.

Associated Conditions: Hepatocellular Carcinoma, Metastatic Colorectal Cancer (CRC), Metastatic Gastrointestinal Stromal Tumor (GIST), Locally advanced Gastrointestinal stromal tumor, Unresectable Gastrointestinal stromal tumor

Clinical Trials

Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer

Phase 2

Withdrawn

Conditions: CCR5
Microsatellite Stable
Metastatic
Colorectal Cancer

Interventions: Drug: 700mg leronlimab weekly dose
Drug: 80mg Regorafenib at week 1
Drug: 120mg Regorafenib at week2
Drug: 160 mg Regorafenib at week 3

First Posted Date: 2023-02-16

Last Posted Date: 2023-02-17

Lead Sponsor: CytoDyn, Inc.

Registration Number: NCT05730673

Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

Recruiting

Conditions: Hepatocellular Carcinoma Non-resectable

Interventions: Procedure: TACE
Drug: apatinib plus camrelizumab
Drug: Bevacizumab Biosimilar IBI305 plus sintilimab
Drug: Bevacizumab plus Atezolizumab
Drug: Lenvatinib
Drug: Anti-PD-1 monoclonal antibody
Drug: Donafenib
Drug: Sorafenib
Drug: Regorafenib

First Posted Date: 2023-02-08

Last Posted Date: 2024-06-13

Lead Sponsor: Tongji Hospital

Target Recruit Count: 300

Registration Number: NCT05717738

Locations: 🇨🇳
Optical Valley branch of Tongji hospital, Wuhan, Hubei, China
🇨🇳
The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China
🇨🇳
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

and more 1 locations

Combined HAIC, TKI/anti-VEGF and ICIs As Conversion Therapy for Unresectable Hepatocellular Carcinoma

Recruiting

Conditions: Hepatocellular Carcinoma Non-resectable

Interventions: Procedure: HAIC
Drug: Bevacizumab plus Atezolizumab
Drug: apatinib plus camrelizumab
Drug: Bevacizumab Biosimilar IBI305 plus sintilimab
Drug: Donafenib
Drug: Sorafenib
Drug: Lenvatinib
Drug: Regorafenib
Drug: Anti-PD-1 monoclonal antibody

First Posted Date: 2023-02-06

Last Posted Date: 2025-03-25

Lead Sponsor: Ze-yang Ding, MD

Target Recruit Count: 300

Registration Number: NCT05713994

Locations: 🇨🇳
The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China
🇨🇳
TongjiHospital, Wuhan, Hubei, China

Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy

Phase 1

Recruiting

Conditions: Advanced Colorectal Adenocarcinoma
Advanced Microsatellite Stable Colorectal Carcinoma
Metastatic Colorectal Adenocarcinoma
Metastatic Microsatellite Stable Colorectal Carcinoma
Stage III Colorectal Cancer AJCC V8
Stage IV Colorectal Cancer AJCC V8

Interventions: Biological: Balstilimab
Procedure: Biospecimen Collection
Biological: Botensilimab
Procedure: Computed Tomography
Drug: Regorafenib

First Posted Date: 2023-01-05

Last Posted Date: 2024-08-05

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 63

Registration Number: NCT05672316

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Biliary Systemic Tumours

Phase 1

Recruiting

Conditions: Advanced Biliary Systemic Tumours That Has Failed at Least One Prior Systemic Therapy

Interventions: Drug: Cadonilimab Injection
Drug: Regorafenib

First Posted Date: 2022-12-09

Last Posted Date: 2022-12-09

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 30

Registration Number: NCT05644392

Locations: 🇨🇳
Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, China

A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular Carcinoma

Phase 1

Recruiting

Conditions: Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy

Interventions: Drug: Cadonilimab Injection
Drug: Regorafenib

First Posted Date: 2022-12-09

Last Posted Date: 2022-12-09

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 30

Registration Number: NCT05644379

Locations: 🇨🇳
Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, China

Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma

Phase 2

Recruiting

Conditions: Liver Cancer
Hepatocellular Carcinoma

Interventions: Drug: Regorafenib Oral Product

First Posted Date: 2022-11-18

Last Posted Date: 2023-10-04

Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Target Recruit Count: 28

Registration Number: NCT05622136

Locations: 🇧🇷
ICESP - Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Biological: favezelimab/pembrolizumab
Drug: regorafenib
Drug: TAS-102

First Posted Date: 2022-10-31

Last Posted Date: 2025-03-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 94

Registration Number: NCT05600309

Locations: 🇨🇳
Hainan General Hospital ( Site 1177), Haikou, Hainan, China
🇨🇳
Fujian Province Cancer Hospital ( Site 1178), Fuzhou, Fujian, China
🇨🇳
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 1159), Guangzhou, Guangdong, China

and more 21 locations