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, unresecta...

Associated Conditions
Hepatocellular Carcinoma, Metastatic Colorectal Cancer (CRC), Metastatic Gastrointestinal Stromal Tumor (GIST), Locally advanced Gastrointestinal stromal tumor, Unresectable Gastrointestinal stromal tumor
Associated Therapies
-

Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy

Phase 2
Conditions
Interventions
First Posted Date
2015-07-17
Last Posted Date
2021-04-05
Lead Sponsor
Yonsei University
Target Recruit Count
36
Registration Number
NCT02501551
Locations
🇰🇷

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

Regorafenib in Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-06-09
Last Posted Date
2022-08-11
Lead Sponsor
University of Rochester
Target Recruit Count
27
Registration Number
NCT02466009
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

University of Rochester, Rochester, New York, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

and more 1 locations

Study of Regorafenib and Sildenafil for Advanced Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-06-09
Last Posted Date
2020-02-20
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
32
Registration Number
NCT02466802
Locations
🇺🇸

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Study of Regorafenib for Urothelial Cancer Following Chemotherapy (UAB 1477)

First Posted Date
2015-06-01
Last Posted Date
2020-08-06
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
17
Registration Number
NCT02459119
Locations
🇺🇸

Wayne State University, Detroit, Michigan, United States

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

First Posted Date
2015-05-12
Last Posted Date
2021-06-23
Lead Sponsor
AHS Cancer Control Alberta
Registration Number
NCT02439723
Locations
🇨🇦

Cross Cancer Institute, Edmonton, Alberta, Canada

Study of Colorectal Cancer Patients (Stage IIIC) With Either Regorafenib or Standard of Care (No Treatment) After Adjuvant FOLFOX

First Posted Date
2015-04-24
Last Posted Date
2020-02-10
Lead Sponsor
US Oncology Research
Target Recruit Count
24
Registration Number
NCT02425683
Locations
🇺🇸

24 Sites, Including Dallas, TX, Ocala, FL, Denver, CO, Florida, United States

Regorafenib in Combination With Paclitaxel in Advanced Oesophagogastric Carcinoma

First Posted Date
2015-04-02
Last Posted Date
2019-10-22
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
47
Registration Number
NCT02406170
Locations
🇳🇱

Academic Medical Center, Medical Oncology, Amsterdam, Netherlands

A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2015-03-30
Last Posted Date
2019-01-29
Lead Sponsor
Georgetown University
Target Recruit Count
10
Registration Number
NCT02402036
Locations
🇺🇸

Georgetown University, Washington, District of Columbia, United States

A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

First Posted Date
2015-03-17
Last Posted Date
2024-12-05
Lead Sponsor
UNICANCER
Target Recruit Count
163
Registration Number
NCT02389244
Locations
🇫🇷

Hopital Jean Monjoz, Besancon, France

🇫🇷

Institut Bergonie, Bordeaux, France

🇫🇷

Centre Francois Baclesse, Caen, France

and more 16 locations

Activity of Regorafenib in Combination With Chemotherapy in Patients With Advanced Biliary Tract Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-03-11
Last Posted Date
2020-01-10
Lead Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Target Recruit Count
66
Registration Number
NCT02386397
Locations
🇫🇷

Centre Val d'Aurelle, Montpellier, France

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