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

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Phase 2

Recruiting

Conditions: Gastrointestinal Stromal Tumors

Interventions: Drug: Sunitinib
Drug: Regorafenib

First Posted Date: 2022-05-09

Last Posted Date: 2024-10-26

Lead Sponsor: University of Miami

Target Recruit Count: 48

Registration Number: NCT05366816

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer

Phase 3

Active, not recruiting

Conditions: Colorectal Neoplasms

Interventions: Drug: Nivolumab-relatlimab FDC
Drug: Regorafenib
Drug: TAS-102

First Posted Date: 2022-04-14

Last Posted Date: 2025-01-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 700

Registration Number: NCT05328908

Locations: 🇧🇪
Local Institution - 0120, Leuven, Belgium
🇨🇭
Local Institution - 0057, Aarau, AG, Switzerland
🇧🇪
Local Institution - 0070, Edegem, Belgium

and more 136 locations

HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure

Not Applicable

Not yet recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Procedure: Hepatic Artery Infusion Chemotherapy
Procedure: Transarterial Chemoembolization
Drug: Regorafenib
Drug: Immune Checkpoint Inhibitors

First Posted Date: 2022-02-10

Last Posted Date: 2022-02-10

Lead Sponsor: The Central Hospital of Lishui City

Target Recruit Count: 176

Registration Number: NCT05233358

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

Phase 3

Active, not recruiting

Conditions: Colorectal Cancer (CRC)

Interventions: Drug: Trifluridine and Tipiracil
Drug: Sotorasib
Drug: Panitumumab
Drug: Regorafenib

First Posted Date: 2022-01-20

Last Posted Date: 2025-04-15

Lead Sponsor: Amgen

Target Recruit Count: 160

Registration Number: NCT05198934

Locations: 🇯🇵
Saitama Cancer Center, Kitaadachi-gun, Saitama, Japan
🇺🇸
Kelsey Research Foundation, Houston, Texas, United States
🇺🇸
Northwest Georgia Oncology Centers PC, Marietta, Georgia, United States

and more 100 locations

Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer

Phase 2

Recruiting

Conditions: Stage IB Hepatocellular Carcinoma AJCC v8
Stage II Hepatocellular Carcinoma AJCC v8
Stage III Hepatocellular Carcinoma AJCC v8
Stage IIIA Hepatocellular Carcinoma AJCC v8

Interventions: Biological: Durvalumab
Drug: Regorafenib

First Posted Date: 2022-01-18

Last Posted Date: 2025-01-24

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 30

Registration Number: NCT05194293

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 2 locations

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Phase 2

Recruiting

Conditions: Advanced Cancer
Solid Tumor
Haematological Malignancy

Interventions: Drug: Cobimetinib
Drug: Trastuzumab+Pertuzumab
Drug: Trametinib
Drug: Dabrafenib+Trametinib
Drug: Abemaciclib
Drug: Tepotinib
Drug: Dabrafenib
Drug: Pemigatinib
Drug: Regorafenib
Drug: Alectinib
Drug: Vismodegib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Vemurafenib
Drug: Apalutamide

First Posted Date: 2021-12-16

Last Posted Date: 2024-07-15

Lead Sponsor: Helsinki University Central Hospital

Target Recruit Count: 250

Registration Number: NCT05159245

Locations: 🇫🇮
Turku University Hospital Cancer Centre, Turku, Varsinais-Suomi, Finland
🇫🇮
Kuopio University Hospital, Kuopio, Finland
🇫🇮
Oulu University Hospital OYS Cancer Center, Oulu, Finland

and more 2 locations

Regorafenib After Progression on Atezolizumab Plus Bevacizumab in Advanced HCC

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: regorafenib

First Posted Date: 2021-11-26

Last Posted Date: 2023-04-26

Lead Sponsor: CHA University

Target Recruit Count: 40

Registration Number: NCT05134532

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of
🇰🇷
CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, Korea, Republic of

A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer

Phase 2

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: MAX-40279-01
Drug: regorafenib

First Posted Date: 2021-11-22

Last Posted Date: 2021-12-06

Lead Sponsor: Maxinovel Pty., Ltd.

Target Recruit Count: 130

Registration Number: NCT05130021

Locations: 🇨🇳
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Regorafenib Combined With Fulvestrant in Recurrent Low-Grade Serous Ovarian Cancer

Phase 2

Recruiting

Conditions: Ovarian Cancer
Serous Ovarian Cancer

Interventions: Drug: Regorafenib
Drug: Fulvestrant

First Posted Date: 2021-11-09

Last Posted Date: 2024-12-11

Lead Sponsor: Sarah K. Lynam MD

Target Recruit Count: 31

Registration Number: NCT05113368

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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)

Phase 3

Completed

Conditions: Colorectal Cancer

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

First Posted Date: 2021-10-01

Last Posted Date: 2025-05-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 441

Registration Number: NCT05064059

Locations: 🇨🇳
Fujian Province Cancer Hospital ( Site 1178), Fuzhou, Fujian, China
🇨🇳
Guangxi Medical University Affiliated Tumor Hospital ( Site 1158), Nanning, Guangxi, China
🇨🇳
Wuhan Union Hospital Cancer Center ( Site 1162), Wuhan, Hubei, China

and more 149 locations

Drug Development Updates

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