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
Associated Therapies
-

Phase II Study of Regorafenib as Maintenance Therapy

First Posted Date
2019-01-04
Last Posted Date
2024-12-10
Lead Sponsor
Centre Oscar Lambret
Target Recruit Count
127
Registration Number
NCT03793361
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

CHRU Besançon, Besançon, France

🇫🇷

Centre François Baclesse, Caen, France

and more 17 locations

Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer

First Posted Date
2018-10-19
Last Posted Date
2024-08-22
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
52
Registration Number
NCT03712943
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

First Posted Date
2018-10-05
Last Posted Date
2018-10-05
Lead Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Target Recruit Count
41
Registration Number
NCT03698253
Locations
🇨🇳

Chung-Ho Memorial Hospital, Kaohsiung Medical University:, Kaohsiung, Taiwan

Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer

First Posted Date
2018-09-05
Last Posted Date
2024-10-10
Lead Sponsor
University of Southern California
Target Recruit Count
75
Registration Number
NCT03657641
Locations
🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Study Maintenance Regorafenib vs Placebo, no Progression Patients After I Line Chemotherapy Metastatic Gastric Cancer

Phase 2
Conditions
Interventions
First Posted Date
2018-08-13
Last Posted Date
2022-09-07
Lead Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Target Recruit Count
120
Registration Number
NCT03627728
Locations
🇮🇹

Struttura Complessa di OncologiaIRCCS- Istituto in Tecnologie Avanzate e Modelli Assistenziali in Oncologia Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

First Posted Date
2018-06-13
Last Posted Date
2023-11-07
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
96
Registration Number
NCT03555149
Locations
🇫🇷

Centre Leon Berard, Lyon, France

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

and more 12 locations

Regorafenib and Methotrexate in Treating Participants With Recurrent or Metastatic KRAS Mutated Non-Small Cell Lung Cancer

First Posted Date
2018-05-11
Last Posted Date
2023-08-01
Lead Sponsor
Stanford University
Target Recruit Count
22
Registration Number
NCT03520842
Locations
🇺🇸

Stanford University School of Medicine, Palo Alto, California, United States

A Study of CS1003 in Subjects With Advanced Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-03-23
Last Posted Date
2022-02-18
Lead Sponsor
CStone Pharmaceuticals
Target Recruit Count
108
Registration Number
NCT03475251
Locations
🇦🇺

Scientia Clinical Research Ltd, Randwick, New South Wales, Australia

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Phase 3
Completed
Conditions
Interventions
First Posted Date
2018-03-14
Last Posted Date
2022-10-06
Lead Sponsor
Blueprint Medicines Corporation
Target Recruit Count
476
Registration Number
NCT03465722
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Northwestern Medicine, Chicago, Illinois, United States

🇺🇸

The University of Chicago Medical Center, Chicago, Illinois, United States

and more 109 locations
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