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 Second Line Treatment of Metastatic or Advanced Upper GI Cancers

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2014-09-16
Last Posted Date
2018-01-11
Lead Sponsor
University of Utah
Target Recruit Count
5
Registration Number
NCT02241720
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Regorafenib in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction Who Have Completed Chemoradiation Therapy and Surgery

First Posted Date
2014-09-09
Last Posted Date
2018-10-17
Lead Sponsor
Academic and Community Cancer Research United
Target Recruit Count
3
Registration Number
NCT02234180
Locations
🇺🇸

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

🇺🇸

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

🇺🇸

Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

and more 7 locations

Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-07-21
Last Posted Date
2023-12-05
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
26
Registration Number
NCT02195011
Locations
🇺🇸

Tennessee Oncology PLLC, Nashville, Tennessee, United States

🇺🇸

Florida Cancer Specialists - North, Saint Petersburg, Florida, United States

🇺🇸

Research Medical Center, Kansas City, Missouri, United States

[18F]FLT-PET as a Predictive Imaging Biomaker of Treatment Responses to Regorafenib

First Posted Date
2014-06-26
Last Posted Date
2024-10-04
Lead Sponsor
Asan Medical Center
Target Recruit Count
68
Registration Number
NCT02175095
Locations
🇰🇷

Asan Medical Center, Seoul, Songpa, Korea, Republic of

Regorafenib as Single Agent in Patients With Metastatic Colorectal Cancer (mCRC) With Any RAS or BRAF Mutation Previously Treated With FOLFOXIRI Plus Bevacizumab

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2014-06-26
Last Posted Date
2017-08-01
Lead Sponsor
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Target Recruit Count
15
Registration Number
NCT02175654
Locations
🇪🇸

Spanish Cooperative Group for Digestive Tumour Therapy (TTD), Madrid, Spain

Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST

First Posted Date
2014-06-16
Last Posted Date
2021-06-14
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
14
Registration Number
NCT02164240
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study of Ruxolitinib in Colorectal Cancer Patients

First Posted Date
2014-04-22
Last Posted Date
2018-02-13
Lead Sponsor
Incyte Corporation
Target Recruit Count
396
Registration Number
NCT02119676

Safety Study of Regorafenib With PF-03446962 to Treat Colorectal Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-04-17
Last Posted Date
2019-03-14
Lead Sponsor
Duke University
Target Recruit Count
11
Registration Number
NCT02116894
Locations
🇺🇸

Duke Cancer Center, Duke University Medical Center, Durham, North Carolina, United States

Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-04-16
Last Posted Date
2021-10-12
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
39
Registration Number
NCT02115542
Locations
🇺🇸

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

🇺🇸

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇺🇸

VCU Massey Cancer Center, Richmond, Virginia, United States

Regorafenib in Patients with Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-03-28
Last Posted Date
2024-11-11
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
38
Registration Number
NCT02098538
Locations
🇺🇸

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

🇺🇸

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States

and more 1 locations
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