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Regorafenib

Generic Name
Regorafenib
Brand Names
Stivarga
Drug Type
Small Molecule
Chemical Formula
C21H15ClF4N4O3
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

Regorafenib Alone or in Combination With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Phase 2
Recruiting
Conditions
Microsatellite Stable Metastatic Colorectal Cancer
Interventions
Radiation: Radiotherapy
First Posted Date
2023-07-27
Last Posted Date
2023-07-27
Lead Sponsor
Fudan University
Target Recruit Count
90
Registration Number
NCT05963490
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, China

Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer

Completed
Conditions
Metastatic Colorectal Adenocarcinoma
First Posted Date
2023-07-12
Last Posted Date
2023-07-12
Lead Sponsor
Hunan Cancer Hospital
Target Recruit Count
103
Registration Number
NCT05942768
Locations
🇨🇳

Hunan Cancer hospital, Changsha, Hunan, China

Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)

Phase 2
Withdrawn
Conditions
Colorectal Cancer
Colon Cancer
Rectum Cancer
Interventions
First Posted Date
2023-06-12
Last Posted Date
2024-04-29
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT05900648

The Safety and Efficacy of HAIC+Tislelizumab+Regorafenib in Patients With Colorectal Liver Metastases

Phase 2
Recruiting
Conditions
Colorectal Liver Metastases
Interventions
First Posted Date
2023-05-26
Last Posted Date
2023-05-26
Lead Sponsor
Peking University Cancer Hospital & Institute
Target Recruit Count
20
Registration Number
NCT05877001
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, China

An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions

Active, not recruiting
Conditions
Metastatic Colorectal Cancer (mCRC)
Interventions
First Posted Date
2023-05-03
Last Posted Date
2025-04-17
Lead Sponsor
Bayer
Target Recruit Count
818
Registration Number
NCT05839951
Locations
🇺🇸

Many locations, Whippany, New Jersey, United States

Phase Ib / Regorafenib With Conventional Chemotherapy/Newly Diagnosed Patients/ Multimetastatic Ewing Sarcoma

Phase 1
Recruiting
Conditions
Bone Cancer
Interventions
First Posted Date
2023-04-26
Last Posted Date
2024-11-28
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
24
Registration Number
NCT05830084
Locations
🇦🇺

Perth Children's Hospital, Perth, Australia

🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇮🇹

Istituto Nazionale dei Tumori, Milan, Italy

and more 3 locations

Efficacy and Safety of Regorafenib Maintenance Therapy in Patients With Metastatic Colorectal Cancer (mCRC)

Not Applicable
Recruiting
Conditions
Colorectal Cancer
Interventions
First Posted Date
2023-04-18
Last Posted Date
2023-07-14
Lead Sponsor
Wei Zhang
Target Recruit Count
30
Registration Number
NCT05818267
Locations
🇨🇳

Department of Colorectal Surgery in Changhai Hospital, Shanghai, Shanghai, China

Regorafenib Alone or in Combined With Transcatheter Arterial ChEmoembolization in Treatment of Advanced Hepatocellular Carcinoma After First Line Targeted Therapy

Recruiting
Conditions
Hepatocellular Carcinoma
Transcatheter Arterial ChEmoembolization
Regorafenib
Interventions
Procedure: TACE
First Posted Date
2023-04-13
Last Posted Date
2023-04-13
Lead Sponsor
WenBo Guo
Target Recruit Count
192
Registration Number
NCT05811481
Locations
🇨🇳

FirstSunYetSen, Guangzhou, Guangdong, China

Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases

Phase 3
Recruiting
Conditions
Colorectal Cancer Liver Metastases
Regorafenib
Interventions
First Posted Date
2023-04-03
Last Posted Date
2023-05-15
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
126
Registration Number
NCT05794971
Locations
🇨🇳

Bo Zhang, Guangdong, Guangzhou, China

Chidamide + Regorafenib in Hepatocellular Carcinoma (HCC)

Phase 1
Terminated
Conditions
Hepatocellular Carcinoma (HCC)
Interventions
First Posted Date
2023-03-16
Last Posted Date
2025-03-11
Lead Sponsor
Great Novel Therapeutics Biotech & Medicals Corporation
Target Recruit Count
7
Registration Number
NCT05770882
Locations
🇨🇳

Chang Gung Memorial Hospital, Kaohsiung, Kaohsiung, Taiwan

🇨🇳

China Medical University Hospital, Taichung, Taiwan

🇨🇳

National Cheng Kung University Hospital, Tainan, Taiwan

and more 2 locations
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