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

Cryoablation Combined with Sintilimab Plus Regorafenib in Previously Treated Colorectal Cancer Liver Metastasis

Phase 2

Recruiting

Conditions: Liver Metastases
Colorectal Cancer Metastatic

Interventions: Drug: Sintilimab
Drug: Regorafenib
Combination Product: US/CT-guided Percutaneous Cryoablation

First Posted Date: 2021-09-27

Last Posted Date: 2025-02-27

Lead Sponsor: Fudan University

Target Recruit Count: 25

Registration Number: NCT05057052

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Regorafenib Combined With PD-1 Inhibitor Therapy for Second-line Treatment of Hepatocellular Carcinoma

Phase 2

Recruiting

Conditions: Hepatocellular Carcinoma
PD-1 Inhibitor
Regorafenib

Interventions: Drug: Regorafenib
Drug: PD-1 inhibitor

First Posted Date: 2021-09-17

Last Posted Date: 2023-03-29

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 20

Registration Number: NCT05048017

Locations: 🇨🇳
Hai-Tao Zhao, Beijing, Beijing, China

cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC

Conditions: Transarterial Chemoembolization
Regorafenib
HCC
Hepatic Arterial Infusion Chemotherapy

Interventions: Drug: Regorafenib
Device: cTACE/DEB-TACE-HAIC

First Posted Date: 2021-08-27

Last Posted Date: 2021-09-02

Lead Sponsor: Peking University Cancer Hospital & Institute

Target Recruit Count: 60

Registration Number: NCT05025592

A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)

Phase 3

Terminated

Conditions: Advanced Hepatocellular Carcinoma (HCC)

Interventions: Drug: camrelizumab；Rivoceranib
Drug: Rivoceranib
Drug: Sorafenib
Drug: Regorafenib

First Posted Date: 2021-08-02

Last Posted Date: 2022-09-01

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 1

Registration Number: NCT04985136

Locations: 🇨🇳
Chinese PLA General Hospital, Beijing, Beijing, China

RegoNivo vs Standard of Care Chemotherapy in AGOC

Phase 3

Active, not recruiting

Conditions: Gastro-Oesophageal Cancer

Interventions: Drug: Regorafenib
Drug: Docetaxel
Biological: Nivolumab
Drug: Paclitaxel
Drug: Irinotecan
Drug: Trifluridine/Tipracil

First Posted Date: 2021-05-10

Last Posted Date: 2024-05-16

Lead Sponsor: Australasian Gastro-Intestinal Trials Group

Target Recruit Count: 450

Registration Number: NCT04879368

Locations: 🇦🇺
Austin Health, Melbourne, Victoria, Australia
🇦🇹
Medizinische Universitaet Wien, Vienna, Austria
🇦🇹
Landesklinikum Wiener Neustadt, Wiener Neustadt, Austria

and more 91 locations

Evaluation of Treatment PERSOnalization Based on Its Therapeutic Monitoring in Patients with Metastatic Colorectal Cancer Treated with REgorafenib

Phase 4

Active, not recruiting

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: Regorafenib

First Posted Date: 2021-05-05

Last Posted Date: 2024-11-15

Lead Sponsor: Rennes University Hospital

Target Recruit Count: 110

Registration Number: NCT04874207

Locations: 🇫🇷
Institut Daniel Hollard, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France
🇫🇷
CHU Caen, Caen, France
🇫🇷
AP-HP Henri Mondor, Créteil, France

and more 6 locations

T-Cell Therapy (ECT204) in Adults With Advanced HCC

Phase 2

Recruiting

Conditions: Hepatocellular Carcinoma
Liver Cancer, Adult
Liver Neoplasm
Metastatic Liver Cancer

Interventions: Biological: ECT204 T cells
Drug: Regorafenib (STIVARGA®, BAY73-4506)

First Posted Date: 2021-04-28

Last Posted Date: 2025-04-10

Lead Sponsor: Eureka Therapeutics Inc.

Target Recruit Count: 30

Registration Number: NCT04864054

Locations: 🇺🇸
Fred Hutchinson Cancer Center, University of Washington, Seattle, Washington, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Kansas University Medical Center, Principal Investigator:, Westwood, Kansas, United States

and more 2 locations

Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS

Completed

Conditions: Glioblastoma Multiforme

Interventions: Drug: Regorafenib 40 MG Oral Tablet [STIVARGA]

First Posted Date: 2021-03-22

Last Posted Date: 2024-02-08

Lead Sponsor: Istituto Oncologico Veneto IRCCS

Target Recruit Count: 192

Registration Number: NCT04810182

Locations: 🇮🇹
Policlinico Universitario di Bari, Bari, BA, Italy
🇮🇹
IRCCS "Saverio de Bellis", Castellana Grotte, BA, Italy
🇮🇹
Ospedlae S. Martino, Belluno, BL, Italy

and more 26 locations

Carelizumab Combined With Regorafenib in the Treatment of HCC（CARE-2020）

Phase 2

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Regorafenib Pill&Camrelizumab

First Posted Date: 2021-03-19

Last Posted Date: 2021-06-30

Lead Sponsor: Nanfang Hospital, Southern Medical University

Target Recruit Count: 69

Registration Number: NCT04806243

Locations: 🇨🇳
NanFang Hospital of Southern Medical University, Guangzhou, Guangdong, China

SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma

Phase 2

Active, not recruiting

Conditions: Osteosarcoma in Children
Osteosarcoma Recurrent
Osteosarcoma Metastatic
Osteosarcoma

Interventions: Drug: Regorafenib 40 MG
Drug: Regorafenib 20MG
Drug: Nivolumab

First Posted Date: 2021-03-18

Last Posted Date: 2025-04-18

Lead Sponsor: Sarcoma Alliance for Research through Collaboration

Target Recruit Count: 48

Registration Number: NCT04803877

Locations: 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸
Cincinnati Children's, Cincinnati, Ohio, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

and more 5 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy