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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 in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers

Phase 2
Recruiting
Conditions
Metastatic Colorectal Cancer
Interventions
Procedure: Blood sample
Other: Quality of life questionnaires
Procedure: Biopsy
Combination Product: Regorafenib + metronomic chemotherapy
First Posted Date
2024-05-22
Last Posted Date
2024-12-24
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
174
Registration Number
NCT06425133
Locations
🇫🇷

CHU d'Auxerre, Auxerre, France

🇫🇷

Centre Hospitalier Universitaire de Besançon, Besançon, France

🇫🇷

CH de Colmar, Colmar, France

and more 7 locations

An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States

Completed
Conditions
Advanced Gastrointestinal Stromal Tumor
Interventions
First Posted Date
2024-03-20
Last Posted Date
2025-05-20
Lead Sponsor
Bayer
Target Recruit Count
136
Registration Number
NCT06321055
Locations
🇺🇸

Bayer, Whippany, New Jersey, United States

A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

Phase 1
Not yet recruiting
Conditions
Colorectal Cancer Metastatic
Interventions
Biological: T3011 hepatic artery infusion
First Posted Date
2024-02-28
Last Posted Date
2024-02-29
Lead Sponsor
China Medical University, China
Target Recruit Count
8
Registration Number
NCT06283303

A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

Phase 1
Not yet recruiting
Conditions
Colorectal Cancer Metastatic
Interventions
Biological: BioTTT001 hepatic artery infusion
First Posted Date
2024-02-28
Last Posted Date
2024-02-29
Lead Sponsor
China Medical University, China
Target Recruit Count
40
Registration Number
NCT06283134

Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial)

Phase 2
Recruiting
Conditions
Meningioma, Malignant
Interventions
Drug: Local Standard of Care
First Posted Date
2024-02-23
Last Posted Date
2025-03-13
Lead Sponsor
Istituto Oncologico Veneto IRCCS
Target Recruit Count
104
Registration Number
NCT06275919
Locations
🇮🇹

Policlinico San Martino, Genova, Italy

🇮🇹

Spedali Riuniti, Livorno, Italy

🇮🇹

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy

and more 13 locations

A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies

Phase 2
Active, not recruiting
Conditions
Solid Malignant Tumors
Interventions
First Posted Date
2024-02-07
Last Posted Date
2025-04-22
Lead Sponsor
Bayer
Target Recruit Count
13
Registration Number
NCT06246643
Locations
🇫🇷

Hôpital Beaujon - Clichy, Clichy, France

🇫🇷

Hopital Claude Huriez - Lille, Lille, France

🇫🇷

Hôpital Paul Brousse - Villejuif, Villejuif, France

and more 4 locations

A Clinical Study of T3011 in Combination With Regorafenib in Patients With Advanced Colorectal Cancer

Phase 1
Recruiting
Conditions
Advanced Colorectal Cancer
Interventions
First Posted Date
2024-01-11
Last Posted Date
2024-01-11
Lead Sponsor
West China Hospital
Target Recruit Count
15
Registration Number
NCT06200363
Locations
🇨🇳

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

Phase 3
Recruiting
Conditions
Advanced Colorectal Cancer
Interventions
First Posted Date
2024-01-10
Last Posted Date
2024-03-15
Lead Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Target Recruit Count
120
Registration Number
NCT06199973
Locations
🇨🇳

Shanghai East Hospital, Shanghai, Shanghai, China

A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment

Active, not recruiting
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2023-11-18
Last Posted Date
2025-03-12
Lead Sponsor
Bayer
Target Recruit Count
200
Registration Number
NCT06137170
Locations
🇪🇸

Many Locations, Multiple Locations, Spain

KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Phase 2
Recruiting
Conditions
Digestive System Cancers
Interventions
First Posted Date
2023-10-25
Last Posted Date
2023-10-26
Lead Sponsor
Peking University Cancer Hospital & Institute
Target Recruit Count
39
Registration Number
NCT06099821
Locations
🇨🇳

Peking University Cancer Hospital, Beijing, China

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