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

PAnitumumab REchallenge Followed by REgorafenib Versus the Reverse Sequence

Phase 2

Active, not recruiting

Conditions: Colorectal Cancer

Interventions: Drug: Panitumumab
Drug: Regorafenib

First Posted Date: 2021-03-08

Last Posted Date: 2025-02-14

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 214

Registration Number: NCT04787341

Locations: 🇮🇹
U.O. Oncologia 2 Universitaria, Pisa, PI, Italy

The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers

Phase 1

Recruiting

Conditions: Advanced Biliary Tract Cancer

Interventions: Drug: Durvalumab
Drug: Regorafenib

First Posted Date: 2021-03-04

Last Posted Date: 2024-02-23

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 40

Registration Number: NCT04781192

Locations: 🇺🇸
University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States
🇺🇸
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
🇺🇸
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States

and more 1 locations

Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7

Phase 3

Active, not recruiting

Conditions: Carcinoma, Hepatocellular

Interventions: Procedure: Loco-regional therapy
Drug: Regorafenib in combination with pembrolizumab

First Posted Date: 2021-03-02

Last Posted Date: 2025-05-15

Lead Sponsor: Translational Research in Oncology

Target Recruit Count: 496

Registration Number: NCT04777851

Locations: 🇺🇸
UCLA Santa Monica Hematology Oncology, Santa Monica, California, United States
🇧🇪
UCL SAINT LUC - UC Louvain, Brussels, Belgium
🇧🇪
Antwerp University Hospital, Edegem, Belgium

and more 23 locations

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Phase 3

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: pembrolizumab
Drug: regorafenib
Drug: TAS-102 (trifluridine and tipiracil)
Drug: lenvatinib

First Posted Date: 2021-03-01

Last Posted Date: 2024-10-29

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 480

Registration Number: NCT04776148

Locations: 🇨🇦
NSHA-QEII Health Sciences Centre-Dickson Bldg-Dept. of Medical Oncology ( Site 0200), Halifax, Nova Scotia, Canada
🇯🇵
Shizuoka Cancer Center ( Site 1706), Nagaizumi, Shizuoka, Japan
🇩🇰
Herlev and Gentofte Hospital-Department of Oncology ( Site 0704), Copenhagen, Hovedstaden, Denmark

and more 92 locations

Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer

Conditions: Advanced Colorectal Carcinoma

First Posted Date: 2021-02-25

Last Posted Date: 2021-02-25

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 100

Registration Number: NCT04771715

Locations: 🇨🇳
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer

Phase 2

Active, not recruiting

Conditions: Esophagogastric Cancer
HER2-Negative

Interventions: Drug: regorafenib
Drug: nivolumab
Drug: FOLFOX chemotherapy with oxaliplatin

First Posted Date: 2021-02-17

Last Posted Date: 2025-03-19

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 39

Registration Number: NCT04757363

Locations: 🇺🇸
Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

Regorafenib Plus Sintilimab vs. Regorafenib as the Second-line Treatment for HCC

Phase 2

Active, not recruiting

Conditions: Hepatocellular Carcinoma Non-resectable

Interventions: Drug: Regorafenib + sintilimab
Drug: Regorafenib

First Posted Date: 2021-01-22

Last Posted Date: 2022-11-10

Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Target Recruit Count: 166

Registration Number: NCT04718909

Locations: 🇨🇳
the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Phase 2

Recruiting

Conditions: Colorectal Cancer; Lung Cancer

Interventions: Drug: TATE and pembrolizumab
Drug: TAS-102 pill
Drug: Regorafenib Pill

First Posted Date: 2021-01-08

Last Posted Date: 2024-11-22

Lead Sponsor: Teclison Ltd.

Target Recruit Count: 110

Registration Number: NCT04701476

Locations: 🇺🇸
University of California, Irvine Medical Center, Orange, California, United States
🇨🇳
Chung Shan Medical University Hospital, Taichung, Taiwan
🇨🇳
China Medical University Hsinchu Hospital, Hsinchu, Taiwan

Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Regorafenib (Stivarga, BAY73-4506)

First Posted Date: 2021-01-06

Last Posted Date: 2025-05-13

Lead Sponsor: Bayer

Target Recruit Count: 95

Registration Number: NCT04696055

Locations: 🇫🇷
Center Hospitalier Michallon - Grenoble, Grenoble Cedex 9, France
🇫🇷
Hopital Claude Huriez - Lille, Lille, France
🇫🇷
Hôpital de la Croix Rousse, Lyon, France

and more 36 locations

An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.

Phase 1

Active, not recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Etrumadenant
Drug: Regorafenib
Drug: AB680
Drug: Zimberelimab
Drug: Bevacizumab
Drug: m-FOLFOX-6 regimen

First Posted Date: 2020-12-09

Last Posted Date: 2025-05-08

Lead Sponsor: Arcus Biosciences, Inc.

Target Recruit Count: 227

Registration Number: NCT04660812

Locations: 🇫🇷
Clinique Sainte Anne, Strasbourg, France
🇮🇹
Ircc Istituto Per La Ricerca E La Cura Del Cancro Di Candiolo Oncologia Medica, Candiolo, Italy
🇮🇹
IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis, Castellana Grotte, Italy

and more 48 locations

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